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Completed

NCT Number: NCT04494620

Evaluating Oral Visual Inspection in the Control of Oral Cancer

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.

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Key information

Conditions

Oral Cancer Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Stomatognathic Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Visual Inspection of Oral Cavity for Precancers and Cancer

Diagnostic Test

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 outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

International Agency for Research on Cancer

Other

Collaborators

  • Regional Cancer Centre, Trivandrum, India

Registry information

Official study title

Randomized Intervention Trial to Evaluate Oral Visual Inspection in the Control of Oral Cancer

Important dates

Study start
1996
Primary completion
2004
Study completion
2014
First posted
Jul 31, 2020
Registry last updated
Jul 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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