NCT04494620

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
191,873

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 1996

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1996

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2004

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2014

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 31, 2020

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

9 years

First QC Date

July 16, 2020

Last Update Submit

July 28, 2020

Conditions

Oral Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    15 years

Secondary Outcomes (1)

  • Oral Cavity Cancer Incidence

    15 years

Study Arms (2)

Control Arm

NO INTERVENTION

Standard of Care

Intervention Arm

ACTIVE COMPARATOR

Visual Inspection of Oral Cavity for Precancers and Cancer

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

Interventions

Visual Inspection of Oral Cavity for Precancers and CancerDIAGNOSTIC_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.

Intervention Arm

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 23265945RESULT

  • 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.

    PMID: 15936419RESULT

  • 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.

    PMID: 33449824DERIVED

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Study Officials

  • Kunnambath Ramadas, MD, PhD

    Regional Cancer Centre, Trivandrum, India

    PRINCIPAL INVESTIGATOR

  • Rengaswamy Sankaranarayanan, MD

    International Agency for Research on Cancer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2020

First Posted

July 31, 2020

Study Start

January 1, 1996

Primary Completion

December 31, 2004

Study Completion

December 31, 2014

Last Updated

July 31, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share