Status:
RECRUITING
Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
American Society of Clinical Oncology
National Cancer Institute (NCI)
Conditions:
Head and Neck Neoplasm
Carcinoma, Squamous Cell
Eligibility:
All Genders
18+ years
Brief Summary
Circulating tumor DNA (ctDNA) is a blood-based test that measures dying or dead cancer cells that are already circulating in the blood. In this study, the investigators will enroll patients who are pl...
Detailed Description
The investigators will take a piece of the tumor from the surgery and determine if they can identify mutations, or changes in the genetic makeup of the cells due to cancer, that are specific to the tu...
Eligibility Criteria
Inclusion
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Consent for the use of any residual material from biopsy and/or surgical resection (archival tissue) and serial blood draws will be required for enrollment.
- Age ≥ 18 years of age on day of signing informed consent
- Newly diagnosed, histologically confirmed squamous cell carcinoma of the head and neck, including the following subtypes: oral cavity, oropharynx, larynx
- Must be planning to undergo gross total resection of the primary tumor with curative intent at UNC-CH hospital
- No prior, definitive therapy to primary tumor. Must meet one of the following clinical stages: T3-T4 (if T1/T2 must have nodal involvement), Any N, M0
- Patient must be amenable to receiving adjuvant therapy with radiotherapy +/- systemic therapy, as clinically indicated, based on either standard of care (SOC) or appropriate clinical trial.
- Diagnostic tumor material must be available for correlative analysis
- Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee
Exclusion
- Has known evidence of metastatic disease based on clinical or radiographic studies
- Women who are pregnant or nursing
- History of another primary malignancy in the last 5 years prior to registration. Patients with history of in situ cancer or basal or localized squamous cell skin cancers are eligible.
- Patients with primary skin cancers of the head and neck, including basal or squamous cell cancers
- Prior chemotherapy, IP, biologic, or hormonal therapy for HNSCC treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
Key Trial Info
Start Date :
January 14 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 2 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04099290
Start Date
January 14 2020
End Date
February 2 2026
Last Update
January 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599