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Evaluating Oral Visual Inspection in the Control of Oral Cancer

Primary Purpose

Oral Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Visual Inspection of Oral Cavity for Precancers and Cancer
Sponsored by
International Agency for Research on Cancer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Oral Cancer

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Residing in 13 study clusters in Trivandrum City, Kerala

Exclusion Criteria:

  • Diagnosis with oral cancer prior to study
  • Bedridden subjects
  • Subjects suffering from open tuberculosis or other debilitating diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Control Arm

    Intervention Arm

    Arm Description

    Standard of Care

    Visual Inspection of Oral Cavity for Precancers and Cancer

    Outcomes

    Primary Outcome Measures

    Oral Cancer Death Rate
    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.

    Secondary Outcome Measures

    Oral Cavity Cancer Incidence
    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.

    Full Information

    First Posted
    July 16, 2020
    Last Updated
    July 28, 2020
    Sponsor
    International Agency for Research on Cancer
    Collaborators
    Regional Cancer Centre Trivandrum
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04494620
    Brief Title
    Evaluating Oral Visual Inspection in the Control of Oral Cancer
    Official Title
    Randomized Intervention Trial to Evaluate Oral Visual Inspection in the Control of Oral Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 1996 (Actual)
    Primary Completion Date
    December 31, 2004 (Actual)
    Study Completion Date
    December 31, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    International Agency for Research on Cancer
    Collaborators
    Regional Cancer Centre Trivandrum

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oral Cancer

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    191873 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Arm
    Arm Type
    No Intervention
    Arm Description
    Standard of Care
    Arm Title
    Intervention Arm
    Arm Type
    Active Comparator
    Arm Description
    Visual Inspection of Oral Cavity for Precancers and Cancer
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Visual Inspection of Oral Cavity for Precancers and Cancer
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Oral Cancer Death Rate
    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.
    Time Frame
    15 years
    Secondary Outcome Measure Information:
    Title
    Oral Cavity Cancer Incidence
    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.
    Time Frame
    15 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Residing in 13 study clusters in Trivandrum City, Kerala Exclusion Criteria: Diagnosis with oral cancer prior to study Bedridden subjects Subjects suffering from open tuberculosis or other debilitating diseases
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kunnambath Ramadas, MD, PhD
    Organizational Affiliation
    Regional Cancer Centre, Trivandrum, India
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Rengaswamy Sankaranarayanan, MD
    Organizational Affiliation
    International Agency for Research on Cancer
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23265945
    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.
    Results Reference
    result
    PubMed Identifier
    15936419
    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.
    Results Reference
    result
    PubMed Identifier
    33449824
    Citation
    Cheung LC, Ramadas K, Muwonge R, Katki HA, Thomas G, Graubard BI, Basu P, Sankaranarayanan R, Somanathan T, Chaturvedi AK. Risk-Based Selection of Individuals for Oral Cancer Screening. J Clin Oncol. 2021 Feb 20;39(6):663-674. doi: 10.1200/JCO.20.02855. Epub 2021 Jan 15.
    Results Reference
    derived

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    Evaluating Oral Visual Inspection in the Control of Oral Cancer

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