A study to collect images from oral cavity of participating subjects to build an artificial intelligence-based tool for supporting the early detection of oral cancers.
- Registration Number
- CTRI/2022/05/042447
- Lead Sponsor
- Oraicle Biosciences Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3000
A subject will be considered eligible for inclusion in this study only if ALL of the following criteria apply:
1. Subject (or legally acceptable representative) understands and agrees to comply with planned study procedures and provides informed consent prior to initiation of study procedures
2. Male & Female adults =18 to < 65 years of age at the time of screening & enrolment.
3. Subject reporting to the site with some kind of oral lesions.
A subject will not be eligible for inclusion in this study if ANY of the following criteria apply:
1. If the subject has participated in another clinical trial in the last 8 weeks before coming at Visit 1.
2. Subject having any other reason which may interfere with the study in the opinion of the Principal Investigator.
3. Subject is blind or falls under the category of vulnerable population. e.g., members of a group with hierarchical structure (e.g. prisoners armed forces personnel, staff and students of medical, nursing and pharmacy academic institutions), patients with incurable diseases, unemployed or impoverished persons, patients in emergency situation, ethnic minority groups, homeless persons, nomads, refugees, minors or other incapable of personally giving consent.
4. If the subject’s mouth does not open wide enough for oral cavity examinations and image acquisition.
5. If according to the judgment of the investigator Subject needs more than 2 biopsy(ies) for assessment after informed consent and oral cavity examination
6. Subjects for whom biopsy(ies) were done for the target lesion(s) more than 60 days from the date of consent.
7. Pregnant or breastfeeding female subjects.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To validate the Artificial Intelligence (AI) algorithm by comparing the output of the algorithm on category of the lesions and the diagnosis of the same images made by investigator capturing the images at the site.Timepoint: Screening Visit, Visit 1 and Visit 2
- Secondary Outcome Measures
Name Time Method oneTimepoint: None