Mobile Oral Cancer Screening In Limited Resource Setting
- Conditions
- Leukoplakia and other disturbancesof oral epithelium, including tongue, (2) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,
- Registration Number
- CTRI/2019/11/022167
- Lead Sponsor
- National Institute of Health
- Brief Summary
Thisproject is a multicentric study, in India at three sub-centers. The aim of this research is to empower the health care workers in ruralIndia to identify oral & pharyngeal lesions with a mobile phone. The deviceacts as “Point of Care†diagnosis for early detection of Oral Cancer andapproach creates an opportunity to connect specialists to rural population,facilitates timely referrals and follow up. Study aimed at Field validation of mobileintraoral system for Oral cancer in LMIC settings.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 6400
- Clinically Suspicious oral Lesions (Including leukoplakia, erythroplakia, Lichen planus, benign lesions- epithelial tumors, ulcers, vesiculobullous lesions like pemphigus vulgaris) 2.
- History of previously treated OSCC, with no current evidence of cancer recurrence at least for 6 months after cessation of treatment.
- Presence of recently diagnosed untreated OSCC or a precancerous lesion 4.
- Individuals positive for tobacco habit.
- Less than or equal to 18 years of age 2.
- Currently undergoing treatment for malignancy 3.
- Pregnancy 4.
- Under treatment for tuberculosis or suffering from any acute illness.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Identification of Oral precancer and cancer by Frontline healthcare providers using point of care diagnostic tool. Interim analysis performed at the end of 12months to assess FHPs for identification of oral precancer and cancer using point of care diagnostic tool | At the end of two and half years to develop AI based algorithm 2. To develop an AI based diagnosis Interim analysis performed at the end of 12months to assess FHPs for identification of oral precancer and cancer using point of care diagnostic tool | At the end of two and half years to develop AI based algorithm
- Secondary Outcome Measures
Name Time Method To evaluate the agreement between FHPs/ Onsite specialist/ Remote specialist/ AI algorithm To evaluate the agreement between the remote diagnosis/ Biopsy
Trial Locations
- Locations (3)
Christian Institute of Health Sciences and Research
🇮🇳Dimapur, NAGALAND, India
KLE Society’s Institute of Dental Sciences
🇮🇳Bangalore, KARNATAKA, India
Mazumdar Shaw Medical Center
🇮🇳Bangalore, KARNATAKA, India
Christian Institute of Health Sciences and Research🇮🇳Dimapur, NAGALAND, IndiaDr Rohan Michael RameshPrincipal investigator917085055422roan.ramesh@gmail.com