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Validating the efficacy of multiple point-of-care diagnostic tools in early detection of oral cancer

Oral Potentially Malignant Lesion Atlas Project: Validating the efficacy of novel, Point-of-Care diagnostics and developing an integrated multidimensional, prognostic nomogram - OPML-PoCD

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/10/058794
Enrollment
5000
Registered
2023-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K132- Leukoplakia and other disturbancesof oral epithelium, including tongue Health Condition 2: K135- Oral submucous fibrosis Health Condition 3: K137- Other and unspecified lesions of oral mucosa

Interventions

Intervention1: Nil: Nil

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
1. Multiple, validated, PoC assays evaluated for their comparative efficacy in screening/early detection of OPML 2. A Resource-setting based positioning of the assay systems in the various levels of the national healthcare system 3. Accuracy of the PoC assays in periodic surveillance of OPML progression 4. A pan-omic, immune and microbiome profile of patients based on their susceptibility to relapse post-surgical excision and/or malignant transformation. 5. A prognostic nomogram integrating clinical, imaging, saliva/cytology marker profiles, histology and omics data Timepoint: 3 years to achieve first objective 57 months to evaluate the efficacy of PoC assay 57 months to develop prognostic model 5 years to develop atlas of opml—

Secondary

MeasureTime frame
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—

Countries

India

Contacts

Public ContactDr Praveen Birur N

Mazumdar Shaw center for translational research

amritha.suresh@gmail.com8105114670

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026