<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/NCT04494620</url>
  </required_header>
  <id_info>
    <org_study_id>RCC-IEC-Sept 2002</org_study_id>
    <nct_id>NCT04494620</nct_id>
  </id_info>
  <brief_title>Evaluating Oral Visual Inspection in the Control of Oral Cancer</brief_title>
  <official_title>Randomized Intervention Trial to Evaluate Oral Visual Inspection in the Control of Oral Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Agency for Research on Cancer</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Regional Cancer Centre Trivandrum</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>International Agency for Research on Cancer</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>
      Cluster-randomized controlled trial in Trivandrum district, Kerala, India to evaluate the&#xD;
      effect of triennial screening for oral cavity cancer using visual inspection on oral cancer&#xD;
      mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study population consisted of 13 administrative regions (clusters) in Trivandrum&#xD;
      district, Kerala, southern Indian. 7 clusters were randomly assigned to the intervention arm&#xD;
      (3 rounds of oral visual inspection conducted 3 years apart) and were compared to the&#xD;
      remaining 6 clusters assigned to a control arm that received standard of care. The&#xD;
      eligibility criteria were all healthy subjects aged 35 and older, without a personal history&#xD;
      of oral cancer. Informed consent was signed by each participant. The intervention arm&#xD;
      consisted of 96,517 participants and the control group consisted of 95,356 participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 1996</start_date>
  <completion_date type="Actual">December 31, 2014</completion_date>
  <primary_completion_date type="Actual">December 31, 2004</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The control group received standard of care while the intervention group received 3 rounds of screening with visual inspection, each 3 years apart. At the 9th year of the study, once significant oral cancer mortality reduction following 3 rounds of screening among the high-risk subjects in the intervention arm was confirmed, the control arm was offered 1 round of screening with visual inspection while the intervention group was offered a 4th round of screening.</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oral Cancer Death Rate</measure>
    <time_frame>15 years</time_frame>
    <description>Information on all deaths were collected from the municipal and district death registers, hospital medical records, death records of churches and mosques, hospital visits by the population cancer registry staff and by project health workers. Cancer cases were coded by the ICD-O 3rd edition codes and cause of death was coded using ICD-10 by the registry and project staff blinded to study group allocation. Deaths were attributed to oral cancer if the patient had histologically or clinically confirmed oral cancer, lymph nodes or distant metastasis at the time of death or had died due to complications of oral cancer treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oral Cavity Cancer Incidence</measure>
    <time_frame>15 years</time_frame>
    <description>Information on incident oral cancer cases were obtained from the Trivandrum population-based cancer registry, hospital cancer registry of the RCC and medical records departments of other hospitals treating oral cancer patients. Collection of information was blinded to study group assignment of cases. The staging of oral cancers was done according to the UICC TNM staging system.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">191873</enrollment>
  <condition>Oral Cancer</condition>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of Care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Visual Inspection of Oral Cavity for Precancers and Cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Visual Inspection of Oral Cavity for Precancers and Cancer</intervention_name>
    <description>Participants were invited for 3 rounds of oral cavity cancer screening, conducted 3-years apart. Screening was conducted by health workers trained to perform visual inspection of the oral mucosa and identify potential precancerous lesions or oral cancer. Lesions found were referred to a weekly clinic for further evaluation by dentists and oncologists with experience in the diagnosis of oral lesions. Oral precancerous lesions were surgically excised whenever possible and those with confirmed oral cancer were referred for appropriate treatment with surgery, radiotherapy, and/or chemotherapy.</description>
    <arm_group_label>Intervention Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Residing in 13 study clusters in Trivandrum City, Kerala&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis with oral cancer prior to study&#xD;
&#xD;
          -  Bedridden subjects&#xD;
&#xD;
          -  Subjects suffering from open tuberculosis or other debilitating diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kunnambath Ramadas, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Regional Cancer Centre, Trivandrum, India</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rengaswamy Sankaranarayanan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Agency for Research on Cancer</affiliation>
  </overall_official>
  <results_reference>
    <citation>Sankaranarayanan R, Ramadas K, Thara S, Muwonge R, Thomas G, Anju G, Mathew B. Long term effect of visual screening on oral cancer incidence and mortality in a randomized trial in Kerala, India. Oral Oncol. 2013 Apr;49(4):314-21. doi: 10.1016/j.oraloncology.2012.11.004. Epub 2012 Dec 21.</citation>
    <PMID>23265945</PMID>
  </results_reference>
  <results_reference>
    <citation>Sankaranarayanan R, Ramadas K, Thomas G, Muwonge R, Thara S, Mathew B, Rajan B; Trivandrum Oral Cancer Screening Study Group. Effect of screening on oral cancer mortality in Kerala, India: a cluster-randomised controlled trial. Lancet. 2005 Jun 4-10;365(9475):1927-33. doi: 10.1016/S0140-6736(05)66658-5.</citation>
    <PMID>15936419</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mouth Neoplasms</mesh_term>
    <mesh_term>Lip Neoplasms</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/NCT04494620
org study id: RCC-IEC-Sept 2002
nct id: NCT04494620
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cluster-randomized controlled trial in Trivandrum district, Kerala, India to evaluate the
      effect of triennial screening for oral cavity cancer using visual inspection on oral cancer
      mortality.
The study population consisted of 13 administrative regions (clusters) in Trivandrum
      district, Kerala, southern Indian. 7 clusters were randomly assigned to the intervention arm
      (3 rounds of oral visual inspection conducted 3 years apart) and were compared to the
      remaining 6 clusters assigned to a control arm that received standard of care. The
      eligibility criteria were all healthy subjects aged 35 and older, without a personal history
      of oral cancer. Informed consent was signed by each participant. The intervention arm
      consisted of 96,517 participants and the control group consisted of 95,356 participants.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The control group received standard of care while the intervention group received 3 rounds of screening with visual inspection, each 3 years apart. At the 9th year of the study, once significant oral cancer mortality reduction following 3 rounds of screening among the high-risk subjects in the intervention arm was confirmed, the control arm was offered 1 round of screening with visual inspection while the intervention group was offered a 4th round of screening.
primary purpose: Screening
masking: None (Open Label)
measure: Oral Cancer Death Rate
time frame: 15 years
description: Information on all deaths were collected from the municipal and district death registers, hospital medical records, death records of churches and mosques, hospital visits by the population cancer registry staff and by project health workers. Cancer cases were coded by the ICD-O 3rd edition codes and cause of death was coded using ICD-10 by the registry and project staff blinded to study group allocation. Deaths were attributed to oral cancer if the patient had histologically or clinically confirmed oral cancer, lymph nodes or distant metastasis at the time of death or had died due to complications of oral cancer treatment.
measure: Oral Cavity Cancer Incidence
time frame: 15 years
description: Information on incident oral cancer cases were obtained from the Trivandrum population-based cancer registry, hospital cancer registry of the RCC and medical records departments of other hospitals treating oral cancer patients. Collection of information was blinded to study group assignment of cases. The staging of oral cancers was done according to the UICC TNM staging system.
arm group label: Control Arm
arm group type: No Intervention
description: Standard of Care
arm group label: Intervention Arm
arm group type: Active Comparator
description: Visual Inspection of Oral Cavity for Precancers and Cancer
intervention type: Diagnostic Test
intervention name: Visual Inspection of Oral Cavity for Precancers and Cancer
description: Participants were invited for 3 rounds of oral cavity cancer screening, conducted 3-years apart. Screening was conducted by health workers trained to perform visual inspection of the oral mucosa and identify potential precancerous lesions or oral cancer. Lesions found were referred to a weekly clinic for further evaluation by dentists and oncologists with experience in the diagnosis of oral lesions. Oral precancerous lesions were surgically excised whenever possible and those with confirmed oral cancer were referred for appropriate treatment with surgery, radiotherapy, and/or chemotherapy.
arm group label: Intervention Arm
criteria: 
gender: All
minimum age: 35 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kunnambath Ramadas, MD, PhD
role: Principal Investigator
affiliation: Regional Cancer Centre, Trivandrum, India
last name: Rengaswamy Sankaranarayanan, MD
role: Principal Investigator
affiliation: International Agency for Research on Cancer
citation: Sankaranarayanan R, Ramadas K, Thara S, Muwonge R, Thomas G, Anju G, Mathew B. Long term effect of visual screening on oral cancer incidence and mortality in a randomized trial in Kerala, India. Oral Oncol. 2013 Apr;49(4):314-21. doi: 10.1016/j.oraloncology.2012.11.004. Epub 2012 Dec 21.
PMID: 23265945
citation: Sankaranarayanan R, Ramadas K, Thomas G, Muwonge R, Thara S, Mathew B, Rajan B; Trivandrum Oral Cancer Screening Study Group. Effect of screening on oral cancer mortality in Kerala, India: a cluster-randomised controlled trial. Lancet. 2005 Jun 4-10;365(9475):1927-33. doi: 10.1016/S0140-6736(05)66658-5.
PMID: 15936419
responsible party type: Sponsor
mesh term: Mouth Neoplasms
mesh term: Lip Neoplasms
sharing ipd: No