Health Condition 1: C01- Malignant neoplasm of base of tongue Health Condition 2: C021- Malignant neoplasm of border of tongue Health Condition 3: C060- Malignant neoplasm of cheek mucosa Health Condition 4: C020- Malignant neoplasm of dorsal surface of tongue Health Condition 5: C031- Malignant neoplasm of lower gum Health Condition 6: C004- Malignant neoplasm of lower lip, inner aspect Health Condition 7: C048- Malignant neoplasm of overlappingsites of floor of mouth Health Condition 8: C030-
Conditions
Interventions
Intervention1: Biopsy: In this study an oral cavity examination will be done for the subjects and images of the oral cavity will be acquired. There is no drug or device intervention planned.
Sponsors
Oraicle Biosciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Performance metrics (Accuracy, Sensitivity, Specificity and F1 score). At Baseline & Week 2.Timepoint: Performance metrics (Accuracy, Sensitivity, Specificity and F1 score). At Baseline & Week 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: None | — |
Countries
India
Contacts
Public ContactMr Ayan Neogi
Oraicle Biosciences Limited
Outcome results
None listed