Blood test for cancer DNA in head and neck cancer patients
Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma
This study is testing if a blood test that looks for cancer DNA can help doctors understand how head and neck cancer behaves before and after surgery, and see if it can predict if the cancer will come back.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT04099290 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on measuring circulating tumor DNA (ctDNA) in patients with locally advanced head and neck squamous cell carcinoma who are scheduled for surgery. Researchers will analyze how ctDNA levels change before and after surgery and investigate factors that may influence these levels. Additionally, the study aims to determine if the presence of ctDNA post-surgery is linked to cancer recurrence. Blood and tumor samples will be collected to identify specific mutations and develop a targeted test for ctDNA detection.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed, histologically confirmed squamous cell carcinoma of the head and neck who are planning to undergo surgery.
Not a fit: Patients with prior definitive therapy to the primary tumor or those not planning to undergo surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring of cancer recurrence in head and neck cancer patients.
How similar studies have performed: Other studies have shown promise in using ctDNA for monitoring cancer, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Siddharth Sheth, MD — UNC Health Care
- Study coordinator: Siddharth Sheth, MD
- Email: Siddharth.Sheth@unchealth.unc.edu
- Phone: (919) 966-3856
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.