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Mobile Oral Cancer Screening In Limited Resource Setting

Completed
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
Inclusion Criteria
  • 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.
Exclusion Criteria
  • 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
NameTimeMethod
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 diagnosisInterim 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
NameTimeMethod
To evaluate the agreement between FHPs/ Onsite specialist/ Remote specialist/ AI algorithmTo 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, India
Dr Rohan Michael Ramesh
Principal investigator
917085055422
roan.ramesh@gmail.com

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