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

Trial Title: 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

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

Conditions: Official terms:
Mouth Neoplasms
Alcohol Drinking

Conditions: Keywords:
smoking
smoking, cigarette
smoking, tobacco
smokeless tobacco
betel leaf
areca nut
paan masala
alcohol use
Memorial Sloan Kettering Cancer Center
24-148

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: mHealth
Description: 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.
Arm group label: Participants from Varanasi

Other name: Mobile Health

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

Criteria for eligibility:

Study pop:
Field health personnel (FHP) with help of ASHA (a healthcare network in rural areas) will visit household and collect mobile phone numbers in Varanasi.

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Memorial Sloan Kettering Cancer Center (All protocol activites)

Address:
City: New York
Zip: 10065
Country: United States

Status: Recruiting

Contact:
Last name: Milind Rajadhyaksha, PhD

Phone: 646-608-2364

Start date: July 30, 2024

Completion date: July 30, 2031

Lead sponsor:
Agency: Memorial Sloan Kettering Cancer Center
Agency class: Other

Source: Memorial Sloan Kettering Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06535867
http://www.mskcc.org