Health Condition 1: C01- Malignant neoplasm of base of tongue
Conditions
Interventions
Control Intervention1: Dr. Prashanth Upadhyay
Consultant Radiation Oncologist: Apollo Hospitals,
Jubilee Hills,
Hyderabad-500 096
Email: drprashant_1@rediffmail.com
Contact No: 088978 64905
Control In
Sponsors
Sephirah Innovations Pvt. Ltd.
Eligibility
Inclusion criteria
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
Exclusion criteria: Patients with residual disease or recurrent disease will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment of Clinical Samples: 120 cases and 120 healthy controls 2. Diagnosis of HPV Status in Biopsy Specimens: HPV In Situ Hybridization on biopsy specimens 3. Detection of HPV E6 and E7 mRNA/protein in serum and saliva samples by PCR and Elisa. 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 Data generation: 2-15 months Analysis and publication writing: 15-18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Establishment of serum & saliva exosome workflow for detection of HPV-16 biomarkers, including exosome isolation, characterization, downstream processing & profiling. 2. Validation of exosome workflow for exosome protein profiling. 3. Migration to SYBR Chemistry PCR in HPV positive cell lines (SiHa, Caski) & healthy controls. Timepoint: Testing: 2-15 months Statistical Analysis & preparation of final report: 15-18 months | — |
Countries
India
Contacts
Public ContactDr Devjani Ghosh Shrestha
Apollo Hospitals Educational and Research Foundation, Hyderabad
Outcome results
None listed