Evaluating Oral Visual Inspection in the Control of Oral Cancer

Oral Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04494620
• Other study ID #: RCC-IEC-Sept 2002
• Status: Completed
• Phase: N/A
• Start date: January 1, 1996
• Est. completion date: December 31, 2014

Study information

• Verified date: July 2020
• Source: International Agency for Research on Cancer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191873
• Est. completion date: December 31, 2014
• Est. primary completion date: December 31, 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lip Neoplasms
• Mouth Neoplasms
• Oral Cancer

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
International Agency for Research on Cancer	Regional Cancer Centre Trivandrum

References & Publications (2)

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.oraloncolo — View Citation

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(9 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Oral Cavity Cancer Incidence	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.	15 years