Digital Infrared Imaging system for screening and early detection of oral cancer

Not Applicable

Conditions: Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

Registration Number: CTRI/2023/04/051533

Lead Sponsor: ICMR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Study Subjects:

1.Adult patients 18 years and above

2.Confirmed diagnosis of inflammatory/ vascular, potentially malignant and malignant oral lesions as per current WHO diagnostic criteria

Healthy controls:

1.Healthy controls would also be recruited from patients who are reporting to CDER for other routine dental problems, without any type of oral lesions (developmental, traumatic, infectious, reactive, inflammatory, vascular, autoimmune, potentially malignant, malignant) as seen by clinical oral examination

Exclusion Criteria

1. Subjects not willing to participate in the study

2. Subjects with complete trismus

3. Subjects febrile with acute inflammatory oral conditions

4. Subjects with recent history of facial trauma, major intraoral or extraoral surgery

5. Subjects with past history of oral malignancy

6. Subjects who require immediate medical attention for emergency oral/systemic conditions

7. Pregnant women and children

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive: Malignant oral present <br/ ><br>Negative: Normal/ Benign <br/ ><br>Inconclusive: UnknownTimepoint: 18 months; 36 months

Secondary Outcome Measures

Name	Time	Method
Superimposition of the two biopsy site areas selected on clinical and infrared images <br/ ><br> Score <br/ ><br>76-100%4Excellent <br/ ><br>51-75%3V Good <br/ ><br>26-50%2Good <br/ ><br>1-25%1Fair <br/ ><br>0%0Poor <br/ ><br>Timepoint: 3 years