NCT04099290 Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma
| NCT ID | NCT04099290 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UNC Lineberger Comprehensive Cancer Center |
| Condition | Head and Neck Neoplasm |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2020-01-14 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2020-01-14 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 planning to receive surgery to remove their head and neck cancer. The investigators are interested to learn how ctDNA levels change with surgery and over the course of time. The investigators also want to determine if there are certain features of the tumor or the patient themselves that might cause ctDNA to be higher than other patients. Also, the investigators want to explore if the detection of ctDNA following surgery is related to cancer recurrence.
Eligibility 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.
Contact & Investigator
Siddharth Sheth, MD
PRINCIPAL INVESTIGATOR
UNC Health Care
Frequently Asked Questions
Who can join the NCT04099290 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04099290 currently recruiting?
Yes, NCT04099290 is actively recruiting participants. Contact the research team at Siddharth.Sheth@unchealth.unc.edu for enrollment information.
Where is the NCT04099290 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT04099290 clinical trial?
NCT04099290 is sponsored by UNC Lineberger Comprehensive Cancer Center. The principal investigator is Siddharth Sheth, MD at UNC Health Care. The trial plans to enroll 50 participants.