A prospective research study to collect images from oral cavity of participating subjects to test an artificial intelligence-based algorithm for supporting the early detection of oral cancers.

Oraicle Biosciences Limited0 个研究点目标入组 661 人开始时间: 待定最近更新: 2024年7月22日

试验速览

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•A subject will be considered eligible in this study only if All of the following criteria apply:
•1. Subject (or LAR) understands and agrees to comply with planned study procedures and provides informed consent before initiating study procedures.
•2. Male or Female adults equal to or more than 18 to 65 years of age at the time of screening and enrolment.
•3. Subject reporting to the site with at least one oral lesion.

•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. Cancer subjects operated with reconstructive (flap) surgery.
•5. If the subject’s mouth does not open wide enough for oral cavity examinations and image acquisition.
•6. Subjects with unclear oral lesion images.
•7. If according to the judgment of the investigator, subject needs more than 2 biopsy(ies) for assessment after signing informed consent and oral cavity examination.
•8. Subjects for whom biopsy(ies) were done for the target lesion(s) more than 30 days from the date of consent.
•9. If the subject has been operated for oral cancer / or any other oral mucosal lesions.
•10. Pregnant or breast-feeding female subjects.

发起方

Oraicle Biosciences Limited