<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/NCT02238990</url>
  </required_header>
  <id_info>
    <org_study_id>UKSH-HL-14-099</org_study_id>
    <secondary_id>UKSH-HL-14-099</secondary_id>
    <nct_id>NCT02238990</nct_id>
  </id_info>
  <brief_title>Biomarkerscreening in Cervical Cancer and Its Preinvasive Lesions</brief_title>
  <official_title>Biomarkerscreening Via Transcriptome and Methylosome Analysis in Cervical Cancer and Its Preinvasive Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Luebeck</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Luebeck</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The following trial is a multicenter and prospective research trial of the colposcopy unit of&#xD;
      luebeck university and the national research center in Borstel, Germany.&#xD;
&#xD;
      The study is to identify and evaluate new biomarkers in human papilloma virus (HPV)&#xD;
      associated malignancies and its preinvasive lesions of the cervix uteri. Fresh tissue samples&#xD;
      being removed during conizations and/or hysterectomies are to be fixed in HOPE's solution and&#xD;
      analyzed according to their transcriptomes and methylosome. The hereby found candidates are&#xD;
      to be validated using immunohistochemistry and RT [real-time] -PCR [polymerase chain&#xD;
      reaction].&#xD;
&#xD;
      The project is meant to be followed by continuous studies developing a new test describing&#xD;
      the malignant potential of HPV associated genital lesions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Anticipated">December 1, 2030</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2030</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>CIN III (cervical intraepithelial neoplasia) lesions</measure>
    <time_frame>three years</time_frame>
    <description>number of CIN III lesions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cervical cancer</measure>
    <time_frame>three years</time_frame>
    <description>number of cervical cancer probes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HPV</measure>
    <time_frame>three years</time_frame>
    <description>number and type of HPV infection of the analyzed probes</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Evaluation of New Tissue Biomarkers for Cervical Cancer</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      tissue samples of the cervix uteri&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The population is to be recruted from A. patients suffering from cervical cancer B.&#xD;
        patients suffering from preinvasive cervical lesions&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Positive informed consent&#xD;
&#xD;
          -  Patients with suspected preinvasive genital lesion&#xD;
&#xD;
          -  Patients with confirmed genital lesion (both preinvasive and invasive)&#xD;
&#xD;
          -  Contact via dept. of obs/gyn of luebeck university&#xD;
&#xD;
          -  Complete set of data&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incomplete set of data&#xD;
&#xD;
          -  Negative informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Beyer, PD Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Luebeck</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Torsten Goldmann, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Forschungszentrum Borstel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Luebeck University, Department for obstetrics and gynecology</name>
      <address>
        <city>Luebeck</city>
        <state>Schleswig Holstein</state>
        <zip>D-23538</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Apgar BS, Kittendorf AL, Bettcher CM, Wong J, Kaufman AJ. Update on ASCCP consensus guidelines for abnormal cervical screening tests and cervical histology. Am Fam Physician. 2009 Jul 15;80(2):147-55.</citation>
    <PMID>19621855</PMID>
  </reference>
  <reference>
    <citation>Gagne HM. Colposcopy of the vagina and vulva. Obstet Gynecol Clin North Am. 2008 Dec;35(4):659-69; x. doi: 10.1016/j.ogc.2008.10.002.</citation>
    <PMID>19061824</PMID>
  </reference>
  <reference>
    <citation>Massad LS, Jeronimo J, Katki HA, Schiffman M; National Institutes of Health/American Society for Colposcopy and Cervical Pathology Research Group. The accuracy of colposcopic grading for detection of high-grade cervical intraepithelial neoplasia. J Low Genit Tract Dis. 2009 Jul;13(3):137-44. doi: 10.1097/LGT.0b013e31819308d4.</citation>
    <PMID>19550210</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>May 27, 2022</last_update_submitted>
  <last_update_submitted_qc>May 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Luebeck</investigator_affiliation>
    <investigator_full_name>Daniel Alexander Beyer</investigator_full_name>
    <investigator_title>Priv.-Doz.Dr.med.habil.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02238990
org study id: UKSH-HL-14-099
secondary id: UKSH-HL-14-099
nct id: NCT02238990
lead sponsor: 
has dmc: No
The following trial is a multicenter and prospective research trial of the colposcopy unit of
      luebeck university and the national research center in Borstel, Germany.

      The study is to identify and evaluate new biomarkers in human papilloma virus (HPV)
      associated malignancies and its preinvasive lesions of the cervix uteri. Fresh tissue samples
      being removed during conizations and/or hysterectomies are to be fixed in HOPE's solution and
      analyzed according to their transcriptomes and methylosome. The hereby found candidates are
      to be validated using immunohistochemistry and RT [real-time] -PCR [polymerase chain
      reaction].

      The project is meant to be followed by continuous studies developing a new test describing
      the malignant potential of HPV associated genital lesions.
observational model: Cohort
time perspective: Prospective
measure: CIN III (cervical intraepithelial neoplasia) lesions
time frame: three years
description: number of CIN III lesions
measure: cervical cancer
time frame: three years
description: number of cervical cancer probes
measure: HPV
time frame: three years
description: number and type of HPV infection of the analyzed probes
tissue samples of the cervix uteri
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel Beyer, PD Dr.
role: Principal Investigator
affiliation: University of Luebeck
last name: Torsten Goldmann, Prof. Dr.
role: Principal Investigator
affiliation: Forschungszentrum Borstel
facility: 
country: Germany
citation: Apgar BS, Kittendorf AL, Bettcher CM, Wong J, Kaufman AJ. Update on ASCCP consensus guidelines for abnormal cervical screening tests and cervical histology. Am Fam Physician. 2009 Jul 15;80(2):147-55.
PMID: 19621855
citation: Gagne HM. Colposcopy of the vagina and vulva. Obstet Gynecol Clin North Am. 2008 Dec;35(4):659-69; x. doi: 10.1016/j.ogc.2008.10.002.
PMID: 19061824
citation: Massad LS, Jeronimo J, Katki HA, Schiffman M; National Institutes of Health/American Society for Colposcopy and Cervical Pathology Research Group. The accuracy of colposcopic grading for detection of high-grade cervical intraepithelial neoplasia. J Low Genit Tract Dis. 2009 Jul;13(3):137-44. doi: 10.1097/LGT.0b013e31819308d4.
PMID: 19550210
responsible party type: Principal Investigator
investigator affiliation: University of Luebeck
investigator full name: Daniel Alexander Beyer
investigator title: Priv.-Doz.Dr.med.habil.
mesh term: Uterine Cervical Neoplasms