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

NCT ID: NCT06535867

Last Updated: 2025-05-22

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

RECRUITING

Total Enrollment

5122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-30

Study Completion Date

2031-07-30

Brief Summary

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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

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Conditions

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Smoking Smoking, Cigarette Smoking, Tobacco Betel Chewer's Mucosa Tobacco Use Tobacco Smoking Alcohol Drinking Smokeless Tobacco Hyperkeratosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants from Varanasi

Participants will be recruited from Varanasi.

mHealth

Intervention Type DIAGNOSTIC_TEST

The mobile health (mHealth) program 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.

Interventions

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mHealth

The mobile health (mHealth) program 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Mobile Health

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Milind Rajadhyaksha, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center (All protocol activites)

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Milind Rajadhyaksha, PhD

Role: CONTACT

646-608-2364

Aditi Sahu

Role: CONTACT

646-608-1935

Facility Contacts

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Milind Rajadhyaksha, PhD

Role: primary

646-608-2364

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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24-148

Identifier Type: -

Identifier Source: org_study_id

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