Health Condition 1: C01- Malignant neoplasm of base of tongue Health Condition 2: C049- Malignant neoplasm of floor of mouth, unspecified Health Condition 3: C039- Malignant neoplasm of gum, unspecified Health Condition 4: C005- Malignant neoplasm of lip, unspecified, inner aspect Health Condition 5: C069- Malignant neoplasm of mouth, unspecified
Conditions
Interventions
None listed
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. Subjects with 1 or more than 1 year tobacco consumption history.
Exclusion criteria
Exclusion criteria: A subject will not be eligible for inclusion in this study if ANY of the following criteria apply: 1.Subject having any other reason which may interfere with the study in the opinion of the Principal Investigator. 2.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. 3.Cancer subjects operated with reconstructive (flap) surgery. 4.Subject with pre diagnosed lesion and under treatment or evaluation 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 the subject has been operated for oral cancer/ or any other oral mucosal lesions. 8.Pregnant or breast-feeding female subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To screen tobacco users using artificial intelligence-based mobile application for detection and referral of the suspected potentially malignant and cancerous lesions to the designated health care centres.Timepoint: At Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To categorize the screened lesions as non-cancerous, potentially malignant disorders and cancerous as detected by AI based mobile application. 2.To evaluate the sensitivity of AI based mobile application detecting potentially malignant disorders or cancerous lesions using the opinion of the Trained Clinicians. 3.To collect and analyse feedback of the Research team on the utility of AI based mobile application in terms of user friendliness, challenges if any. Timepoint: At Baseline & Day 3 | — |
Countries
India
Contacts
Public ContactMr Ayan Neogi
Oraicle Biosciences Limited
Outcome results
None listed