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Recruiting NCT06535867

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

Observational Smoking Smoking, Cigarette Smoking, Tobacco Betel Chewer's Mucosa

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: mHealth.
Who it may be relevant to
Registry conditions: Smoking, Smoking, Cigarette, Smoking, Tobacco, Betel Chewer's Mucosa. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • Diagnostic test 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.

Primary outcome measures

  • Comparison of mHealth with conventional oral cancer screening [Time frame: Up to 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Memorial Sloan Kettering Cancer Center (All protocol activites) — New York

Identifiers

NCT: NCT06535867 · 24-148

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗