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Evaluating Oral Visual Inspection in the Control of Oral Cancer

NCT ID: NCT04494620

Last Updated: 2020-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

191873 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-01-01

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Oral Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Control Arm

Standard of Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Arm

Visual Inspection of Oral Cavity for Precancers and Cancer

Group Type ACTIVE_COMPARATOR

Visual Inspection of Oral Cavity for Precancers and Cancer

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Exclusion Criteria

* Diagnosis with oral cancer prior to study
* Bedridden subjects
* Subjects suffering from open tuberculosis or other debilitating diseases
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Regional Cancer Centre, Trivandrum, India

OTHER

Sponsor Role collaborator

International Agency for Research on Cancer

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kunnambath Ramadas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Regional Cancer Centre, Trivandrum, India

Rengaswamy Sankaranarayanan, MD

Role: PRINCIPAL_INVESTIGATOR

International Agency for Research on Cancer

References

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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.

Reference Type RESULT
PMID: 23265945 (View on PubMed)

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.

Reference Type RESULT
PMID: 15936419 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33449824 (View on PubMed)

Other Identifiers

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RCC-IEC-Sept 2002

Identifier Type: -

Identifier Source: org_study_id