Clinical trial · Interventional
Evaluating Oral Visual Inspection in the Control of Oral Cancer
Randomized Intervention Trial to Evaluate Oral Visual Inspection in the Control of Oral Cancer
NCT04494620CI-TRIAL-00046331completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Visual Inspection of Oral Cavity for Precancers and Cancer | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control Arm
- description
- Standard of Care
- type
- ACTIVE_COMPARATOR
- label
- Intervention Arm
- description
- Visual Inspection of Oral Cavity for Precancers and Cancer
- interventionNames
- Diagnostic Test: Visual Inspection of Oral Cavity for Precancers and Cancer
Primary outcomes (1)
- measure
- Oral Cancer Death Rate
- timeFrame
- 15 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
Show eligibility criteria text
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
References
Publications (3)
- RESULTSankaranarayanan 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 23265945
- RESULTSankaranarayanan 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 15936419
- DERIVEDCheung 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 33449824