Evaluating Oral Visual Inspection in the Control of Oral Cancer

Overview

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.

Full Title of Study: “Randomized Intervention Trial to Evaluate Oral Visual Inspection in the Control of Oral Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2004

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.

Interventions

  • Diagnostic Test: Visual Inspection of Oral Cavity for Precancers and Cancer
    • 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.

Arms, Groups and Cohorts

  • No Intervention: Control Arm
    • Standard of Care
  • Active Comparator: Intervention Arm
    • Visual Inspection of Oral Cavity for Precancers and Cancer

Clinical Trial Outcome Measures

Primary Measures

  • Oral Cancer Death Rate
    • Time Frame: 15 years
    • 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 Measures

  • Oral Cavity Cancer Incidence
    • Time Frame: 15 years
    • 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.

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 35 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • International Agency for Research on Cancer
  • Collaborator
    • Regional Cancer Centre Trivandrum
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kunnambath Ramadas, MD, PhD, Principal Investigator, Regional Cancer Centre, Trivandrum, India
    • Rengaswamy Sankaranarayanan, MD, Principal Investigator, International Agency for Research on Cancer

Citations Reporting on Results

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.

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.

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