Multidimensional Assessment of Virus-associated Head and Neck Cancer Patients for the Discovery of Predictive Biomarkers to Guide Clinical Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Observe the kinetics of HPV-DNA levels circulating in the blood
Study Overview
Brief Summary
Prospective pilot study, non-interventional, of a biological/radiological nature, which involves the collection of tissue samples, and blood from patients suffering from squamous cell carcinoma of the oropharynx OPSCC for detection of HPV-DNA/RNA and immuno-phenotypic analysis of T cells, study of extracellular vesicles, and dosages of cytokines and chemokines involved in the immune response
Detailed Description
The study involves the collection of tissue samples, and blood from patients suffering from squamous cell carcinoma of the oropharynx OPSCC for detection of HPV-DNA/RNA and immuno-phenotypic analysis of T cells, study of extracellular vesicles, and dosages of cytokines and chemokines involved in the immune response. Radiological images will be collected during diagnosis, treatment and the care path, with exploratory and research purposes only, without the results modifying the care path and the diagnostic-therapeutic process of the patients participants. Molecular analyzes and/or material extraction will not be conducted genomic/protein of any kind. The objective is to observe the kinetics of the levels of HPV-DNA circulating in the blood patients with oropharynx cancers HPV related to the diagnosis and during the care pathway patient. The blood of HPV-negative patients will be tested to confirm that there are no copies of circulating HPV-DNA. The aim is to collect the information necessary to improve understanding and managing HPV-associated OPSCC.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Squamous cell carcinomas of the oropharynx (OPSCC) candidates for surgical
- •Age > 18 years
- •ECOG performance status <_ 2
- •Signature of informed consent (to participate in the study and data processing)
Exclusion Criteria
- •Presence of distant metastases at the time of diagnosis
- •Previous head and neck cancer
Outcomes
Primary Outcomes
Observe the kinetics of HPV-DNA levels circulating in the blood
Time Frame: 24 months
ctHPV DNA levels will be measured by digital PCR, 8 mL of blood will be collected in DNA BCT Streck tubes. The blood will be centrifuged a room temperature and frozen at -80°C until extraction. Total ctDNA will be extracted from 5 mL of plasma using the QIAamp Circulating Nucleic Acid Kit and will be quantified with a Qubit fluorometer. The ddPCR will be performed on a QX-200 platform and analyzed with QuantaSoft software v1.7.4.0917. Probes will be used for conserved regions of HPV E6 for HPV 16. Samples will be run with 5 cfDNA input to 10 ng and titered to optimize ddPCR performance, with a range of 1 to 20 ng of cfDNA total loaded per well. These reactions will be added to a DG8 cartridge along with 60mL of droplet generating oil. The drops will then be transferred to a plate from 96 wells and subjected to thermal cycles with the following conditions: 5 min at 95°C, 40 cycles at 94°C for 30 seconds, 55°C for 1 minute followed by 98°C for 10 min.
Secondary Outcomes
- Isolation of extracellular vesicles(24 months)
- Immuno-phenotyping at the tissue and blood level(24 months)