Evaluating Oral Visual Inspection in the Control of Oral Cancer

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Tongue neoplasm
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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

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.

Study Type

Interventional

Primary Outcome

Oral Cancer Death Rate

Secondary Outcome

 Oral Cavity Cancer Incidence

Condition

Oral Cancer

Intervention

Visual Inspection of Oral Cavity for Precancers and Cancer

Study Arms / Comparison Groups

 Control Arm
Description:  Standard of Care

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Diagnostic Test

Estimated Enrollment

191873

Start Date

January 1, 1996

Completion Date

December 31, 2014

Primary Completion Date

December 31, 2004

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

Gender

All

Ages

35 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Kunnambath Ramadas, MD, PhD, ,

Administrative Informations

NCT ID

NCT04494620

Organization ID

RCC-IEC-Sept 2002

Responsible Party

Sponsor

Study Sponsor

International Agency for Research on Cancer

Collaborators

 Regional Cancer Centre Trivandrum

Study Sponsor

Kunnambath Ramadas, MD, PhD, Principal Investigator, Regional Cancer Centre, Trivandrum, India

Verification Date

July 2020