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
1 other identifier
observational
5,122
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2024
CompletedStudy Start
First participant enrolled
July 30, 2024
CompletedFirst Posted
Study publicly available on registry
August 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2031
May 22, 2025
May 1, 2025
7 years
July 30, 2024
May 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of mHealth with conventional oral cancer screening
To compare the efficacy of conventional screening with mHealth in identification of oral potentially malignant disorders (OPMDs) / oral cancer.
Up to 5 years
Study Arms (1)
Participants from Varanasi
Participants will be recruited from Varanasi.
Interventions
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.
Eligibility Criteria
Field health personnel (FHP) with help of ASHA (a healthcare network in rural areas) will visit household and collect mobile phone numbers in Varanasi.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Milind Rajadhyaksha, PhD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2024
First Posted
August 2, 2024
Study Start
July 30, 2024
Primary Completion (Estimated)
July 30, 2031
Study Completion (Estimated)
July 30, 2031
Last Updated
May 22, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.