1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response (Others) - 


6. For how long will this data be available start date provided 09-10-2029 and end date provided 09-10-2032?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - Nil

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.