Study of measurement of margins of area around tumour
Phase 3
- Conditions
- Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
- Registration Number
- CTRI/2021/03/032015
- Lead Sponsor
- A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Biopsy proven treatment naïve cases of OCSCC who are planned for curative surgery with en-bloc removal
of the tumor with adequate margin
2. In detail assessment of the primary tumour is possible pre-operatively
3. Written informed consent
4. Age more than 18 years
Exclusion Criteria
1. Multifocal disease
2. Clinically evident field cancerisation
3. Previous treatment for oral cavity cancer â?? Surgery /chemo or radiotherapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the difference between the local recurrence free survival (LRFS) between <br/ ><br>intra operative gross examination by the surgeon compared with microscopic <br/ ><br>examination of frozen sections by the pathologist for the assessment of surgical margin <br/ ><br>in patients undergoing surgery for OCSCC.Timepoint: 2 years
- Secondary Outcome Measures
Name Time Method 1.To determine the accuracy of intra operative gross examination by the surgeon <br/ ><br>compared with microscopic examination of frozen sections by the pathologist for the <br/ ><br>assessment of surgical margin <br/ ><br>2. sensitivity, specificity, positive predictive value (PPV) and negative predictive <br/ ><br>value (NPV) of GE and FS for the assessment of surgical marginTimepoint: After 2 years