The Efficacy of Conventional Screening Versus mHealth Screening in Early Detection of Oral Potentially Malignant Disorders and Oral Cancer Amongst the Rural Population of Varanasi: A Prospective and Blinded Study

Recruiting

• Conditions: Smoking, Cigarette; Tobacco Use; Tobacco Smoking; Smoking, Tobacco; Alcohol Drinking; Betel Chewer's Mucosa; Smoking; Smokeless Tobacco Hyperkeratosis
• Interventions: Diagnostic Test: mHealth

• Registration Number: NCT06535867
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

Mobile health (mHealth) will be used for early detection of oral cancer and pre-cancer lesions, and to improve awareness of oral cancer among the population and knowledge of oral cancer diagnosis among frontline health providers. This program is inclusive of long term surveillance to downstage oral cancer in India

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-30
• Study First Submitted: 2024-07-30
• Study First Submitted QC: 2024-07-30
• Study First Posted: 2024-08-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2031-07-30
• Study Completion: 2031-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5122

Inclusion Criteria

Positive for any one or more of the following:

• All individuals aged above 18 years positive for habits (smoking and smokeless tobacco, chewing betel leaf, areca nut, paan masala, and/or regular use of alcohol)
• Clinical signs/symptoms (non-healing ulcers, white/ red/red & white patches in the mouth, restriction of mouth opening and swelling of the neck)
• All individuals aged above 40 irrespective of habit/oral lesions

Exclusion Criteria

• Individuals already diagnosed with oral cancer and undergoing treatment for oral cancer
• Under treatment for tuberculosis or suffering from any acute illness/ debilitating systemic disorders

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants from Varanasi	mHealth	Participants will be recruited from Varanasi.

Primary Outcome Measures

Name	Time	Method
Comparison of mHealth with conventional oral cancer screening	Up to 5 years	To compare the efficacy of conventional screening with mHealth in identification of oral potentially malignant disorders (OPMDs) / oral cancer.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center (All protocol activites); 🇺🇸 New York, New York, United States