Screening and detection of oral cancer
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Men and women above 20 years with OPMD lesions such as leukoplakia, erythroplakia, OSMF, dysplasia and moderate to well differentiated squamous cell carcinoma.
- Registration Number
- CTRI/2017/10/010125
- Lead Sponsor
- Sascan Meditech Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 336
Inclusion Criteria
1. Patients presenting with oral potentially malignant disorder (OPMD) lesions such as leukoplakia, erythroplakia, oral sub mucous fibrosis (OSMF), dysplasia and moderate to well differentiate squamous cell cancer.
2.Healthy Volunteers without tobacco/pan/gutka/arrecanut/cigarette or beedi smoking/alcohol habits and any visible symptoms of other diseases or tissue inflammation in the oral cavity
Exclusion Criteria
1.Previous treatments for cancer.
2.Patients with systemic conditions that contraindicates biopsy.
3.Recent application of any medication orally for at least four weeks.
4.Patients not willing to participate
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Testing the accuracy of the device to locate the most malignant site in a lesion for biopsy.Timepoint: Two weeks of patient enrollment
- Secondary Outcome Measures
Name Time Method 1. Development of an algorithm to discriminate different types and grade cancer. <br/ ><br>2. Determining the diagnostic accuracy of the device for discrimination of OPMDTimepoint: One year from the start of trial