Tumor immune infiltrates as prognostic biomarkers in oral cancer
Not Applicable
Completed
- Conditions
- Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2020/07/026335
- Lead Sponsor
- Kinjal Shankar Majumdar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 111
Inclusion Criteria
1. Histologically proven squamous cell carcinoma of oral cavity.
2. ECOG PS: 0 – 2.
3. Resectable stage I – IV tumours.
Exclusion Criteria
1. Patients with recurrent or residual head and neck cancers or second primaries treated with radiation with or without chemotherapy
2. Presence of synchronous malignancies.
3. Previous history of radiotherapy and/or chemotherapy for any other malignancy.
4. Patients with severe medical illness that preclude full participation in the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A subset of differentially expressed tumor immune infiltarates in tumor-core and tumor-stroma predict 1-year locoregional recurrence and distant metastasis.Timepoint: At the time of surgery, 3 months, 6 months, 9 months and 12 months
- Secondary Outcome Measures
Name Time Method A validated IHC panel to be used as a prognostic biomarker in oral squamous cell carcinoma.Timepoint: IEC approval, training of manpower: April 2020 - June 2020. <br/ ><br>Accrual: July 2020 - February 2021. <br/ ><br>Follow up, data analysis: March 2021 - February 2022.