<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03813576</url>
  </required_header>
  <id_info>
    <org_study_id>2018/00846</org_study_id>
    <nct_id>NCT03813576</nct_id>
  </id_info>
  <brief_title>Acceptability and Efficacy of Self-sampling for Cervical Cancer Screening: A Pilot Study</brief_title>
  <official_title>Acceptability and Efficacy of Self-sampling for Cervical Cancer Screening: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National University Hospital, Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National University Hospital, Singapore</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In Singapore, the current cervical cancer screening uptake among women in Singapore has&#xD;
      remained at low 50% since its introduction in 2004. It has been widely reported that&#xD;
      under-screened women have the highest risk of cervical cancer. Self-sampling HPV DNA&#xD;
      screening may be a solution to the low uptake rates of local women, particularly among the&#xD;
      under-screened population in Singapore. Self-sampling comprises women using a swab to obtain&#xD;
      samples from their vagina.&#xD;
&#xD;
      In this study, we are comparing the sensitivity of detecting HPV positive women using HPV DNA&#xD;
      test with self-sampling using flocked swab with the current physician sampling method. We&#xD;
      also aim to determine acceptability of self-sampling HPV DNA test using flocked swab in&#xD;
      cervical cancer screening. Designed as a feasibility study, it will comprise a prospective&#xD;
      study of 300 women attending clinics in National University Hospital (NUH) and National&#xD;
      Cancer Institute Singapore (NCIS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cervical cancer is one of the leading causes of death worldwide. The recognition that&#xD;
      cervical cancer is caused by persistent oncogenic HPV virus has caused a considerable&#xD;
      paradigm shift in screening and prevention of cervical cancer by the introduction of HPV DNA&#xD;
      test and the HPV vaccine. HPV DNA test as an alternative to the current and more traditional&#xD;
      cytology only screening has been shown to have higher sensitivity in detecting high grade&#xD;
      cervical intraepithelial neoplasia (CIN) to allow for earlier treatment of pre-cancer thus&#xD;
      preventing development of cervical cancer in future. Singapore as the rest of the world are&#xD;
      in the transition toward the paradigm shift of using HPV DNA test as part of the cervical&#xD;
      cancer screening strategy compared to the traditional cytology only screening. However, any&#xD;
      cancer screening program to make an impact, an uptake of 70% of more is desired and currently&#xD;
      this strategy resulting to the reduction in cervical cancer incidence are only seen in&#xD;
      countries adopting an organized cervical cancer screening strategy such as the United&#xD;
      Kingdom. Currently, HPV DNA testing has widely been shown to be higher sensitivity to pick up&#xD;
      pre-cancer and allow for earlier treatment of pre-cancer. Uptake for cervical cancer&#xD;
      screening has remains suboptimal since introduction of the national cervical cancer screening&#xD;
      using cytology only method in 2004.&#xD;
&#xD;
      A study published by Jin et.al. in Singapore Medical Journal in 2013 evaluating the progress&#xD;
      of cervical cancer screening Singapore (CSS) since its introduction showed that CSS did not&#xD;
      make its aim to get 80% uptake for cervical cancer screening for eligible women using&#xD;
      cytology only method&#xD;
&#xD;
      Self-sampling in cervical cancer screening&#xD;
&#xD;
      Cervical cancer screening with HPV DNA test is more sensitive than cytology only method to&#xD;
      detect pre-cancer cervical cells. It is now well established that cervical cancer screening&#xD;
      with HPV DNA test is a much more sensitive method to detect pre-cancer cervical cells&#xD;
      compared to cytology only method.&#xD;
&#xD;
      The traditional way of taking a cervical cancer screening involves a physician inserting a&#xD;
      speculum into the vagina to visualize the cervix and brushing the surface of the cervix using&#xD;
      a cytology brush or spatula. This will collect exfoliated cervical cells to be sent for&#xD;
      cytology review to detect any abnormal or pre-cancerous looking cells. Currently HPV DNA test&#xD;
      is performed using the same method as taking a pap smear. However, various studies have shown&#xD;
      that for HPV DNA test, self-sampling method is a good alternative to physician sampling&#xD;
      (Appendix C). Current self-sampling methods in the market are expensive and not cost&#xD;
      effective especially if targeting under screeners. There are however, various self-sampling&#xD;
      HPV DNA test device in the market. These devices such as the Delphi Screener are expensive&#xD;
      and would not be a cost-effective alternative method for women especially in the under&#xD;
      screeners in Singapore. Studies have shown that those who do not come for regular cervical&#xD;
      cancer screening are usually associated with a lower socioeconomic background. To encourage&#xD;
      the under screeners to take up screening, the method should not only be accessible to them&#xD;
      but also affordable. The Copan Floq swab has already been used in NUH for Chlamydia testing&#xD;
      and it is highly affordable at 3 SGD per swab. Our study would like to determine that using&#xD;
      this affordable swab for self-sampling is as sensitive in detecting high risk HPV as a&#xD;
      physician sampling method.&#xD;
&#xD;
      There is no local data on the acceptability of self-sampling method using a Floq swab among&#xD;
      women in Singapore. The acceptability of self-sampling has been reported to be high among&#xD;
      women especially in the western countries. Women in the Asian population in particular&#xD;
      Singapore may differ in their acceptability of a self-sampling method compared to a physician&#xD;
      sampling method. Self-sampling HPV DNA test will require a woman to insert the cotton swab&#xD;
      into the vagina and currently there is no local data to show wether it is an acceptable&#xD;
      method for women in Singapore for all ages from 25 to 69 years old. The use of tampons is a&#xD;
      much more acceptable method during menstruation in the western country which may influence&#xD;
      the acceptability data of self-sampling in the western countries. However, tampon use is not&#xD;
      a norm in Asian population including Singapore and may be a factor to influence the&#xD;
      acceptability of self-sampling among Singaporean women especially in the older age group.&#xD;
&#xD;
      This study is thus also designed to elucidate this issue. Cervical cancer is a marker of&#xD;
      health disparities. Looking to the future, data has shown that failure to go for cervical&#xD;
      cancer screening, which is a highly preventable disease, may also be linked to failure of&#xD;
      uptake to other screening in a woman. It may also be linked to failure of basic health&#xD;
      screening not only for the woman but also for her family. Hence to overcome barriers for&#xD;
      cervical cancer screening especially in giving women a reliable alternative option may in&#xD;
      future not only help to prevent cervical cancer but also indirectly encourage uptake of other&#xD;
      screening such as breast cancer and colorectal screening for her and her family. Our study&#xD;
      will attempt to address two questions. 1) Does the self-sampling HPV DNA test as sensitive as&#xD;
      the physician sampling HPV DNA test in Singapore? And 2) If Singaporean women have the option&#xD;
      of self-sampling, are they more likely to regularly participate in future cervical cancer&#xD;
      screening.&#xD;
&#xD;
      STUDY DESIGN&#xD;
&#xD;
      The study is a prospective feasibility study composed of healthy women aged between 30-69&#xD;
      years who are attending clinics in NUH will be identified through the gynaecologist. Ethical&#xD;
      approval for this study from the Domain Specific Review Board for O&amp;G is being sought.&#xD;
&#xD;
      Subjects: Three hundred women who meet the inclusion &amp; exclusion below will be invited to&#xD;
      participate and complete the consent process. Those that decline will have age, ethnicity,&#xD;
      education, work status &amp; reason for declining collected.&#xD;
&#xD;
      Study Visit: Each potential participant will initially see their doctor as clinically&#xD;
      intended and offered to participate in the study as identified by each physician in the&#xD;
      clinic. Upon agreeing to participate in the study, each participant will be given a study&#xD;
      information leaflet and introduced to the research coordination for further explanation of&#xD;
      the study and to sign the study consent form. Once consent form is signed, the participant&#xD;
      will be given a study self-sampling kit and instructions on how to perform the self-sampling&#xD;
      (see Appendix A). The participant performed the self-sampling test in the clinic in a private&#xD;
      area and hand over the completed kit to the research coordinator who will label and keep the&#xD;
      sample for process.&#xD;
&#xD;
      Post assessment: On completion, the participant will be invited to complete a 10 to 15&#xD;
      minutes questionnaire to assess women's acceptability on self-sampling method. Upon&#xD;
      completion of the questionnaire, the participant will be awarded a study token of&#xD;
      appreciation prior to leaving the clinic. The participant clinical management will not be&#xD;
      affected by the study.&#xD;
&#xD;
      SAMPLE SIZE AND STATISTICAL ANALYSIS&#xD;
&#xD;
      Data collected for this study will be in a password protected Microsoft Excel software. Only&#xD;
      the primary investigator and co-investigators will have access to the database for the&#xD;
      purpose of data analysis. Sample size was calculated based on the number of women between the&#xD;
      ages of 30 and 69 in Singapore's population (as of June 2017). Using a 95% confidence level,&#xD;
      it was determined that a sample size of 120 - 150 women would be ideal. The sample size was&#xD;
      calculated using G*Power. SPSS will be used to analyze the data collected. Descriptive&#xD;
      analyses will be done on the survey data to get demographic data, and to determine&#xD;
      participants' perceptions and ratings of the self-sampling methods. Multivariate analyses&#xD;
      will be used to determine the sensitivity of the self-sampling method with physician-taken&#xD;
      swab as the reference standard.&#xD;
&#xD;
      Data collected will include:&#xD;
&#xD;
        -  Patient details: Name and NRIC&#xD;
&#xD;
        -  Patient demographics: Age, Race, area code, parity, social economic status&#xD;
&#xD;
        -  Reason for HPV DNA test: Primary screening or secondary screening&#xD;
&#xD;
        -  Screening results:&#xD;
&#xD;
             -  Physician sampling HPV DNA test&#xD;
&#xD;
             -  Self-sampling HPV DNA test&#xD;
&#xD;
        -  Completed questionnaire&#xD;
&#xD;
      Our specific aims are to:&#xD;
&#xD;
        1. To determine the sensitivity of self-sampling method compared to physician sampling&#xD;
           method for HPV DNA test in cervical cancer screening&#xD;
&#xD;
        2. To determine acceptability of self-sampling HPV DNA test using flocked swab in cervical&#xD;
           cancer screening&#xD;
&#xD;
      The study is designed to give a more accurate local view of the sensitivity of floq swab and&#xD;
      acceptability for self-sampling to Singaporean women. Published studies on self-sampling are&#xD;
      mainly from the western countries and perception may not be similar for local women.&#xD;
      Currently available self-sampling in the market are expensive and thus will not be cost&#xD;
      effective if to be introduced to the current Singapore cervical cancer screening program. As&#xD;
      Singapore is also moving towards HPV primary screening in the very near future, this study&#xD;
      will aid in providing the next step to the screening program by introducing a method that can&#xD;
      help to increase uptake of screening in particular in the underscreen population in&#xD;
      Singapore.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 2019</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>All women will undergo a clinical-collected cervical HPV swab and a self-collected vaginal HPV swab and the results of both swabs compared. The women will be randomised to the sequence of which they undergo the clinical-collected swab first or the self-collected swab first.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity and specificity of self-collected HPV swabs</measure>
    <time_frame>1 week (time for results of HPV swab to be analysed)</time_frame>
    <description>To determine the sensitivity of self-sampling method compared to physician sampling method for HPV DNA test in cervical cancer screening</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participant acceptability of self-collected HPV swabs</measure>
    <time_frame>15 minutes (time for questionnaire to be filled in by participant)</time_frame>
    <description>To determine acceptability of self-sampling HPV DNA test using flocked swab in cervical cancer screening</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Cervical Cancer</condition>
  <condition>Cervical Dysplasia</condition>
  <condition>Human Papillomavirus Infection</condition>
  <arm_group>
    <arm_group_label>All participants</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Only 1 arm in the study. All women will undergo both self-collected swab and clinician-collected swab</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Self-collected HPV vaginal swab</intervention_name>
    <description>Patients will be instructed on how to collect a vaginal swab on themselves which will then be processed for presence of HPV DNA.</description>
    <arm_group_label>All participants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria: All women aged between 30-69 years who are attending clinics in NUH.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Women who are pregnant&#xD;
&#xD;
          2. Previous total hysterectomy&#xD;
&#xD;
          3. Previous history of cervical cancer&#xD;
&#xD;
          4. Virgin Intacto&#xD;
&#xD;
          5. Negative Pap smear less than 3 years ago.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>All participants are female to be applicable for cervical cancer screening</gender_description>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ismail Pratt Ida, MBBS</last_name>
    <role>Study Chair</role>
    <affiliation>National University Hospital, Singapore</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Li Min Lim, MBBS</last_name>
    <phone>96564934</phone>
    <email>li_min_lim@nuhs.edu.sg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Grace Ming Fen Grace, MBBS</last_name>
    <phone>96340882</phone>
    <email>grace_chan@nuhs.edu.sg</email>
  </overall_contact_backup>
  <results_reference>
    <citation>Arbyn M, Verdoodt F, Snijders PJ, Verhoef VM, Suonio E, Dillner L, Minozzi S, Bellisario C, Banzi R, Zhao FH, Hillemanns P, Anttila A. Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. Lancet Oncol. 2014 Feb;15(2):172-83. doi: 10.1016/S1470-2045(13)70570-9. Epub 2014 Jan 14.</citation>
    <PMID>24433684</PMID>
  </results_reference>
  <results_reference>
    <citation>Petignat P, Faltin DL, Bruchim I, Tramer MR, Franco EL, Coutlee F. Are self-collected samples comparable to physician-collected cervical specimens for human papillomavirus DNA testing? A systematic review and meta-analysis. Gynecol Oncol. 2007 May;105(2):530-5. doi: 10.1016/j.ygyno.2007.01.023. Epub 2007 Feb 28.</citation>
    <PMID>17335880</PMID>
  </results_reference>
  <results_reference>
    <citation>Latiff LA, Rahman SA, Wee WY, Dashti S, Andi Asri AA, Unit NH, Siah Li SF, Esfehani AJ, Ahmad S. Assessment of the reliability of a novel self-sampling device for performing cervical sampling in Malaysia. Asian Pac J Cancer Prev. 2015;16(2):559-64. doi: 10.7314/apjcp.2015.16.2.559.</citation>
    <PMID>25684487</PMID>
  </results_reference>
  <results_reference>
    <citation>Ketelaars PJW, Bosgraaf RP, Siebers AG, Massuger LFAG, van der Linden JC, Wauters CAP, Rahamat-Langendoen JC, van den Brule AJC, IntHout J, Melchers WJG, Bekkers RLM. High-risk human papillomavirus detection in self-sampling compared to physician-taken smear in a responder population of the Dutch cervical screening: Results of the VERA study. Prev Med. 2017 Aug;101:96-101. doi: 10.1016/j.ypmed.2017.05.021. Epub 2017 Jun 1.</citation>
    <PMID>28579497</PMID>
  </results_reference>
  <results_reference>
    <citation>Jin AZ, Louange EC, Chow KY, Fock CW. Evaluation of the National Cervical Cancer Screening Programme in Singapore. Singapore Med J. 2013 Feb;54(2):96-101. doi: 10.11622/smedj.2013032.</citation>
    <PMID>23462834</PMID>
  </results_reference>
  <results_reference>
    <citation>Dijkstra MG, Heideman DA, van Kemenade FJ, Hogewoning KJ, Hesselink AT, Verkuijten MC, van Baal WM, Boer GM, Snijders PJ, Meijer CJ. Brush-based self-sampling in combination with GP5+/6+-PCR-based hrHPV testing: high concordance with physician-taken cervical scrapes for HPV genotyping and detection of high-grade CIN. J Clin Virol. 2012 Jun;54(2):147-51. doi: 10.1016/j.jcv.2012.02.022. Epub 2012 Mar 23.</citation>
    <PMID>22445557</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 20, 2019</study_first_submitted>
  <study_first_submitted_qc>January 20, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 20, 2019</last_update_submitted>
  <last_update_submitted_qc>January 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>screening</keyword>
  <keyword>cervical cancer</keyword>
  <keyword>primary prevention</keyword>
  <keyword>human papillomavirus infection</keyword>
  <keyword>acceptability</keyword>
  <keyword>feasibility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Papillomavirus Infections</mesh_term>
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
    <mesh_term>Uterine Cervical Dysplasia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03813576
org study id: 2018/00846
nct id: NCT03813576
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In Singapore, the current cervical cancer screening uptake among women in Singapore has
      remained at low 50% since its introduction in 2004. It has been widely reported that
      under-screened women have the highest risk of cervical cancer. Self-sampling HPV DNA
      screening may be a solution to the low uptake rates of local women, particularly among the
      under-screened population in Singapore. Self-sampling comprises women using a swab to obtain
      samples from their vagina.

      In this study, we are comparing the sensitivity of detecting HPV positive women using HPV DNA
      test with self-sampling using flocked swab with the current physician sampling method. We
      also aim to determine acceptability of self-sampling HPV DNA test using flocked swab in
      cervical cancer screening. Designed as a feasibility study, it will comprise a prospective
      study of 300 women attending clinics in National University Hospital (NUH) and National
      Cancer Institute Singapore (NCIS).
Cervical cancer is one of the leading causes of death worldwide. The recognition that
      cervical cancer is caused by persistent oncogenic HPV virus has caused a considerable
      paradigm shift in screening and prevention of cervical cancer by the introduction of HPV DNA
      test and the HPV vaccine. HPV DNA test as an alternative to the current and more traditional
      cytology only screening has been shown to have higher sensitivity in detecting high grade
      cervical intraepithelial neoplasia (CIN) to allow for earlier treatment of pre-cancer thus
      preventing development of cervical cancer in future. Singapore as the rest of the world are
      in the transition toward the paradigm shift of using HPV DNA test as part of the cervical
      cancer screening strategy compared to the traditional cytology only screening. However, any
      cancer screening program to make an impact, an uptake of 70% of more is desired and currently
      this strategy resulting to the reduction in cervical cancer incidence are only seen in
      countries adopting an organized cervical cancer screening strategy such as the United
      Kingdom. Currently, HPV DNA testing has widely been shown to be higher sensitivity to pick up
      pre-cancer and allow for earlier treatment of pre-cancer. Uptake for cervical cancer
      screening has remains suboptimal since introduction of the national cervical cancer screening
      using cytology only method in 2004.

      A study published by Jin et.al. in Singapore Medical Journal in 2013 evaluating the progress
      of cervical cancer screening Singapore (CSS) since its introduction showed that CSS did not
      make its aim to get 80% uptake for cervical cancer screening for eligible women using
      cytology only method

      Self-sampling in cervical cancer screening

      Cervical cancer screening with HPV DNA test is more sensitive than cytology only method to
      detect pre-cancer cervical cells. It is now well established that cervical cancer screening
      with HPV DNA test is a much more sensitive method to detect pre-cancer cervical cells
      compared to cytology only method.

      The traditional way of taking a cervical cancer screening involves a physician inserting a
      speculum into the vagina to visualize the cervix and brushing the surface of the cervix using
      a cytology brush or spatula. This will collect exfoliated cervical cells to be sent for
      cytology review to detect any abnormal or pre-cancerous looking cells. Currently HPV DNA test
      is performed using the same method as taking a pap smear. However, various studies have shown
      that for HPV DNA test, self-sampling method is a good alternative to physician sampling
      (Appendix C). Current self-sampling methods in the market are expensive and not cost
      effective especially if targeting under screeners. There are however, various self-sampling
      HPV DNA test device in the market. These devices such as the Delphi Screener are expensive
      and would not be a cost-effective alternative method for women especially in the under
      screeners in Singapore. Studies have shown that those who do not come for regular cervical
      cancer screening are usually associated with a lower socioeconomic background. To encourage
      the under screeners to take up screening, the method should not only be accessible to them
      but also affordable. The Copan Floq swab has already been used in NUH for Chlamydia testing
      and it is highly affordable at 3 SGD per swab. Our study would like to determine that using
      this affordable swab for self-sampling is as sensitive in detecting high risk HPV as a
      physician sampling method.

      There is no local data on the acceptability of self-sampling method using a Floq swab among
      women in Singapore. The acceptability of self-sampling has been reported to be high among
      women especially in the western countries. Women in the Asian population in particular
      Singapore may differ in their acceptability of a self-sampling method compared to a physician
      sampling method. Self-sampling HPV DNA test will require a woman to insert the cotton swab
      into the vagina and currently there is no local data to show wether it is an acceptable
      method for women in Singapore for all ages from 25 to 69 years old. The use of tampons is a
      much more acceptable method during menstruation in the western country which may influence
      the acceptability data of self-sampling in the western countries. However, tampon use is not
      a norm in Asian population including Singapore and may be a factor to influence the
      acceptability of self-sampling among Singaporean women especially in the older age group.

      This study is thus also designed to elucidate this issue. Cervical cancer is a marker of
      health disparities. Looking to the future, data has shown that failure to go for cervical
      cancer screening, which is a highly preventable disease, may also be linked to failure of
      uptake to other screening in a woman. It may also be linked to failure of basic health
      screening not only for the woman but also for her family. Hence to overcome barriers for
      cervical cancer screening especially in giving women a reliable alternative option may in
      future not only help to prevent cervical cancer but also indirectly encourage uptake of other
      screening such as breast cancer and colorectal screening for her and her family. Our study
      will attempt to address two questions. 1) Does the self-sampling HPV DNA test as sensitive as
      the physician sampling HPV DNA test in Singapore? And 2) If Singaporean women have the option
      of self-sampling, are they more likely to regularly participate in future cervical cancer
      screening.

      STUDY DESIGN

      The study is a prospective feasibility study composed of healthy women aged between 30-69
      years who are attending clinics in NUH will be identified through the gynaecologist. Ethical
      approval for this study from the Domain Specific Review Board for O&G is being sought.

      Subjects: Three hundred women who meet the inclusion & exclusion below will be invited to
      participate and complete the consent process. Those that decline will have age, ethnicity,
      education, work status & reason for declining collected.

      Study Visit: Each potential participant will initially see their doctor as clinically
      intended and offered to participate in the study as identified by each physician in the
      clinic. Upon agreeing to participate in the study, each participant will be given a study
      information leaflet and introduced to the research coordination for further explanation of
      the study and to sign the study consent form. Once consent form is signed, the participant
      will be given a study self-sampling kit and instructions on how to perform the self-sampling
      (see Appendix A). The participant performed the self-sampling test in the clinic in a private
      area and hand over the completed kit to the research coordinator who will label and keep the
      sample for process.

      Post assessment: On completion, the participant will be invited to complete a 10 to 15
      minutes questionnaire to assess women's acceptability on self-sampling method. Upon
      completion of the questionnaire, the participant will be awarded a study token of
      appreciation prior to leaving the clinic. The participant clinical management will not be
      affected by the study.

      SAMPLE SIZE AND STATISTICAL ANALYSIS

      Data collected for this study will be in a password protected Microsoft Excel software. Only
      the primary investigator and co-investigators will have access to the database for the
      purpose of data analysis. Sample size was calculated based on the number of women between the
      ages of 30 and 69 in Singapore's population (as of June 2017). Using a 95% confidence level,
      it was determined that a sample size of 120 - 150 women would be ideal. The sample size was
      calculated using G*Power. SPSS will be used to analyze the data collected. Descriptive
      analyses will be done on the survey data to get demographic data, and to determine
      participants' perceptions and ratings of the self-sampling methods. Multivariate analyses
      will be used to determine the sensitivity of the self-sampling method with physician-taken
      swab as the reference standard.

      Data collected will include:

        -  Patient details: Name and NRIC

        -  Patient demographics: Age, Race, area code, parity, social economic status

        -  Reason for HPV DNA test: Primary screening or secondary screening

        -  Screening results:

             -  Physician sampling HPV DNA test

             -  Self-sampling HPV DNA test

        -  Completed questionnaire

      Our specific aims are to:

        1. To determine the sensitivity of self-sampling method compared to physician sampling
           method for HPV DNA test in cervical cancer screening

        2. To determine acceptability of self-sampling HPV DNA test using flocked swab in cervical
           cancer screening

      The study is designed to give a more accurate local view of the sensitivity of floq swab and
      acceptability for self-sampling to Singaporean women. Published studies on self-sampling are
      mainly from the western countries and perception may not be similar for local women.
      Currently available self-sampling in the market are expensive and thus will not be cost
      effective if to be introduced to the current Singapore cervical cancer screening program. As
      Singapore is also moving towards HPV primary screening in the very near future, this study
      will aid in providing the next step to the screening program by introducing a method that can
      help to increase uptake of screening in particular in the underscreen population in
      Singapore.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All women will undergo a clinical-collected cervical HPV swab and a self-collected vaginal HPV swab and the results of both swabs compared. The women will be randomised to the sequence of which they undergo the clinical-collected swab first or the self-collected swab first.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Sensitivity and specificity of self-collected HPV swabs
time frame: 1 week (time for results of HPV swab to be analysed)
description: To determine the sensitivity of self-sampling method compared to physician sampling method for HPV DNA test in cervical cancer screening
measure: Participant acceptability of self-collected HPV swabs
time frame: 15 minutes (time for questionnaire to be filled in by participant)
description: To determine acceptability of self-sampling HPV DNA test using flocked swab in cervical cancer screening
arm group label: All participants
arm group type: Other
description: Only 1 arm in the study. All women will undergo both self-collected swab and clinician-collected swab
intervention type: Diagnostic Test
intervention name: Self-collected HPV vaginal swab
description: Patients will be instructed on how to collect a vaginal swab on themselves which will then be processed for presence of HPV DNA.
arm group label: All participants
criteria: 
gender: Female
gender based: Yes
gender description: All participants are female to be applicable for cervical cancer screening
minimum age: 30 Years
maximum age: 69 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ismail Pratt Ida, MBBS
role: Study Chair
affiliation: National University Hospital, Singapore
last name: Li Min Lim, MBBS
phone: 96564934
email: li_min_lim@nuhs.edu.sg
last name: Grace Ming Fen Grace, MBBS
phone: 96340882
email: grace_chan@nuhs.edu.sg
citation: Arbyn M, Verdoodt F, Snijders PJ, Verhoef VM, Suonio E, Dillner L, Minozzi S, Bellisario C, Banzi R, Zhao FH, Hillemanns P, Anttila A. Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. Lancet Oncol. 2014 Feb;15(2):172-83. doi: 10.1016/S1470-2045(13)70570-9. Epub 2014 Jan 14.
PMID: 24433684
citation: Petignat P, Faltin DL, Bruchim I, Tramer MR, Franco EL, Coutlee F. Are self-collected samples comparable to physician-collected cervical specimens for human papillomavirus DNA testing? A systematic review and meta-analysis. Gynecol Oncol. 2007 May;105(2):530-5. doi: 10.1016/j.ygyno.2007.01.023. Epub 2007 Feb 28.
PMID: 17335880
citation: Latiff LA, Rahman SA, Wee WY, Dashti S, Andi Asri AA, Unit NH, Siah Li SF, Esfehani AJ, Ahmad S. Assessment of the reliability of a novel self-sampling device for performing cervical sampling in Malaysia. Asian Pac J Cancer Prev. 2015;16(2):559-64. doi: 10.7314/apjcp.2015.16.2.559.
PMID: 25684487
citation: Ketelaars PJW, Bosgraaf RP, Siebers AG, Massuger LFAG, van der Linden JC, Wauters CAP, Rahamat-Langendoen JC, van den Brule AJC, IntHout J, Melchers WJG, Bekkers RLM. High-risk human papillomavirus detection in self-sampling compared to physician-taken smear in a responder population of the Dutch cervical screening: Results of the VERA study. Prev Med. 2017 Aug;101:96-101. doi: 10.1016/j.ypmed.2017.05.021. Epub 2017 Jun 1.
PMID: 28579497
citation: Jin AZ, Louange EC, Chow KY, Fock CW. Evaluation of the National Cervical Cancer Screening Programme in Singapore. Singapore Med J. 2013 Feb;54(2):96-101. doi: 10.11622/smedj.2013032.
PMID: 23462834
citation: Dijkstra MG, Heideman DA, van Kemenade FJ, Hogewoning KJ, Hesselink AT, Verkuijten MC, van Baal WM, Boer GM, Snijders PJ, Meijer CJ. Brush-based self-sampling in combination with GP5+/6+-PCR-based hrHPV testing: high concordance with physician-taken cervical scrapes for HPV genotyping and detection of high-grade CIN. J Clin Virol. 2012 Jun;54(2):147-51. doi: 10.1016/j.jcv.2012.02.022. Epub 2012 Mar 23.
PMID: 22445557
responsible party type: Sponsor
mesh term: Papillomavirus Infections
mesh term: Uterine Cervical Neoplasms
mesh term: Uterine Cervical Dysplasia
sharing ipd: No