Clinical trial · Observational
Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Squamous Cell | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Head and Neck Neoplasm | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood and tumor samples | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Rate of tumor-specific mutation in pre-operative circulating tumor DNA of patients with locally-advanced HNSCC who are receiving surgery for treatment of their primary tumor
- timeFrame
- Time of consent
Secondary outcomes (5)
- measure
- Rate of tumor-specific mutation in post-operative circulating tumor DNA in patients with locally-advanced HNSCC who received surgery for treatment of their primary tumor
- timeFrame
- Post-surgery/pre-treatment, post-surgery/post-treatment (approximately 6 weeks following initiation of treatment and every 3 months up to 2 years), and at disease recurrence if applicable (up to 5 years)
- measure
- Change in ctDNA levels (i.e., copies per mL plasma) over time
- timeFrame
- Time of consent, post-operatively (approximately 1-4 weeks after surgery), post-adjuvant treatment (approximately 6 weeks following initiation of treatment) and follow-up (every 3 months up to 2 years)/recurrence if applicable (up to 5 years)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available