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

Not yet recruiting

Conditions: Leukoplakia and other disturbancesof oral epithelium, including tongue, (2) ICD-10 Condition: K135||Oral submucous fibrosis, (3) ICD-10 Condition: K137||Other and unspecified lesions of oral mucosa,

Registration Number: CTRI/2023/10/058794

Lead Sponsor: Indian Council of Medical Research

Brief Summary: **Background:** This study plans to provide a unified platform for multiple diagnostic adjuncts in screening and early detection of oral cancer.

**Objectives:** Specific Aim 1(SA1): Evaluate the efficacy of multiple Point-of-Care systems for detection and surveillance of oral potentially malignant lesions (OPML). Specific Aim2(SA2): Develop a prognostic model combining clinical/auto-fluorescence images, saliva markers, cytology, histology, multi-omics and microbiome

**Novelty:** *Clinically,* the proposed study is the first effort wherein all major oral cancer diagnostic adjuncts are tested head-to head in a large high-risk cohort for detection/surveillance, establishing their relative benefit in a primary care setting. A prognostic nomogram for relapse/malignant transformation is another significant aim. *Technologically,* the study attempts to document the differences in surface imaging, cellular/salivary marker patterns using multiple PoC adjuncts onto a single platform, integrate them with pan-omics data in the prognostic nomogram and establish a data-centric warehouse for future research.

**Methods** In SA1, subjects (n=5000) with risk habits will be recruited from multicentric locations in North/South India and will undergo PoC detection tests (imaging, saliva, cytology) periodically. Patients who are clinically suspicious for OPML/oral cancer will undergo diagnostic incisional biopsy and high-grade lesions will be referred for excisional biopsy. In SA2, multi-omic profiling will be carried out, integrated with the imaging, cytology, salivary parameters to develop a prognostic model.

**Expected Outcome:** i) Multiple, validated, PoC assays evaluated for their comparative efficacy in screening/early detection and their resource-setting-based positioning ii) A prognostic nomogram integrating clinical/imaging, saliva/cytology marker profiles, histology and omics data. Iii) An open-source, multi-dimensional atlas of OPML during disease progression.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 5000

Inclusion Criteria

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

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	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
5. A prognostic nomogram integrating clinical, imaging, saliva/cytology marker profiles, histology and omics data	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
2. A Resource-setting based positioning of the assay systems in the various levels of the national healthcare system	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
3. Accuracy of the PoC assays in periodic surveillance of OPML progression	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
4. A pan-omic, immune and microbiome profile of patients based on their susceptibility to relapse post-surgical excision and/or malignant transformation.	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 Outcome Measures

Name	Time	Method
1. An open-source data centre with multi-dimension comprehensive atlas of OPML during disease progression and malignant transformation	open source data center will be achieved by end of 5 years

Trial Locations

Locations (4): Homi Bhabha Cancer Hospital
🇮🇳
Varanasi, UTTAR PRADESH, India
KLE Societys Institute of Dental Sciences
🇮🇳
Bangalore, KARNATAKA, India
Mazumdar Shaw Medical Center
🇮🇳
Bangalore, KARNATAKA, India
National Cancer Institute-AIIMS
🇮🇳
Jhajjar, HARYANA, India
Homi Bhabha Cancer Hospital
🇮🇳Varanasi, UTTAR PRADESH, India
Dr Divya Khanna
Principal investigator
8800261044
dkhannakgmc@gmail.com