Validating the efficacy of multiple point-of-care diagnostic tools in early detection of oral cancer
Not Applicable
- Conditions
- Health Condition 1: K132- Leukoplakia and other disturbancesof oral epithelium, including tongueHealth Condition 2: K135- Oral submucous fibrosisHealth Condition 3: K137- Other and unspecified lesions of oral mucosa
- Registration Number
- CTRI/2023/10/058794
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) subjects having history of risk habits (Smoking/chewing tobacco, betel leaf/nut, alcohol) 2) Individuals with positive clinical signs- red or white patches, unhealed ulcer of the mouth that last more than 3 weeks, restriction of mouth opening, and swelling of the neck.
Exclusion Criteria
1) below 18 years of age
2) who presents with acute illness,
3) not consenting for follow-up for 3 years and
4) not consenting for participating in study for imaging or sample collection- saliva and cytology.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Multiple, validated, PoC assays evaluated for their comparative efficacy in screening/early detection of OPML <br/ ><br>2. A Resource-setting based positioning of the assay systems in the various levels of the national healthcare system <br/ ><br>3. Accuracy of the PoC assays in periodic surveillance of OPML progression <br/ ><br>4. A pan-omic, immune and microbiome profile of patients based on their susceptibility to relapse post-surgical excision and/or malignant transformation. <br/ ><br>5. A prognostic nomogram integrating clinical, imaging, saliva/cytology marker profiles, histology and omics data <br/ ><br>Timepoint: 3 years to achieve first objective <br/ ><br>57 months to evaluate the efficacy of PoC assay <br/ ><br>57 months to develop prognostic model <br/ ><br>5 years to develop atlas of opml <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. An open-source data centre with multi-dimension comprehensive atlas of OPML during disease progression and malignant transformationTimepoint: open source data center will be achieved by end of 5 years