Validation of non-invasive, serum and saliva-based Human Papilloma Virus diagnostic panel for head and neck cancers
Not Applicable
- Conditions
- Health Condition 1: C01- Malignant neoplasm of base of tongue
- Registration Number
- CTRI/2024/02/062625
- Lead Sponsor
- Sephirah Innovations Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
The study will include newly diagnosed patients with Oral and Oropharyngeal Squamous Cell Carcinoma. Demographic data and risk factors associated with oral and oropharyngeal cancers will be collected by a patient questionnaire.
Exclusion Criteria
Patients with residual disease or recurrent disease will be excluded from the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Recruitment of Clinical Samples: 120 cases and 120 healthy controls <br/ ><br>2. Diagnosis of HPV Status in Biopsy Specimens: HPV In Situ Hybridization on biopsy specimens <br/ ><br>3. Detection of HPV E6 and E7 mRNA/protein in serum and saliva samples by PCR and Elisa. <br/ ><br>4. Statistical analysis of data, co-relation with clinical disease and determination of sensitivity, specificity, positive and negative predictive value of detection in body fluids as compared to biopsy specimens.Timepoint: Sample collection: 0-12 months <br/ ><br>Data generation: 2-15 months <br/ ><br>Analysis and publication writing: 15-18 months
- Secondary Outcome Measures
Name Time Method 1. Establishment of serum & saliva exosome workflow for detection of HPV-16 biomarkers, including exosome isolation, characterization, downstream processing & profiling. <br/ ><br>2. Validation of exosome workflow for exosome protein profiling. <br/ ><br>3. Migration to SYBR Chemistry PCR in HPV positive cell lines (SiHa, Caski) & healthy controls. <br/ ><br> <br/ ><br>Timepoint: Testing: 2-15 months <br/ ><br>Statistical Analysis & preparation of final report: 15-18 months