Blood test for cancer DNA in head and neck cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Continuous monitoring of microvascular connections: an observational study

  This study will see if the sounds from a device that watches blood flow in a free flap can be turned into a visual signal to help care teams monitor flap healing.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07823283

• Intratumoral injection of N17350 in advanced solid tumors

  Aims to see if injected N17350 can shrink or control tumors in adults with advanced solid cancers who have few other options.

  Recruiting at 7 sites Phase 1/2 Onchilles Pharma Inc · Los Angeles, California and 8 other locations · NCT07339176

• Zanzalintinib with pembrolizumab and cetuximab for recurrent or metastatic head and neck squamous cell cancer

  This trial tests whether adding the oral drug zanzalintinib to pembrolizumab and cetuximab is safe and finds the best dose for adults with recurrent or metastatic head and neck squamous cell cancer.

  Recruiting Phase 1 University of Chicago · Chicago, Illinois · NCT06912087

• Lenvatinib plus pembrolizumab for anal or rectal cancer that progressed after first treatment

  This trial gives lenvatinib with pembrolizumab to people whose anorectal squamous cell cancer has spread or gotten worse after first-line chemotherapy or chemoradiation to see if the combination controls the cancer and is safe.

  Recruiting Phase 2 University of Chicago · Chicago, Illinois · NCT06669572

• Neoadjuvant targeted therapy for lung cancer patients with specific mutations

  This study is testing if a targeted therapy called osimertinib can safely shrink tumors in lung cancer patients with specific mutations before surgery to help improve their treatment outcomes.

  Recruiting Phase 2 The First Affiliated Hospital of Guangzhou Medical University · Guangzhou, Guangdong · NCT06383728

• Identifying biomarkers for HPV-related oropharyngeal cancer

  This study is trying to find specific markers in blood and saliva that can help identify HPV-related throat cancer in patients who are already diagnosed with advanced stages of the disease.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT06356272

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.