Testing blood samples for cancer DNA in head and neck cancer patients
Tumor-informed ctDNA Testing for Minimal Residual Disease Monitoring Following Curative-intent Treatment of Squamous Cell Carcinoma of the Head and Neck.
This study is testing if checking blood samples for cancer DNA can help predict if head and neck cancer patients will have a relapse after their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06606028 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the correlation between circulating tumor DNA (ctDNA) testing and cancer relapse in patients with head and neck squamous cell carcinoma after receiving curative-intent surgery or radiation. The primary objective is to determine the rates of detectable ctDNA within two years post-treatment. Secondary objectives include assessing ctDNA prevalence at diagnosis and its association with survival outcomes and tumor volume. Participants will provide blood and tissue samples for analysis over a two-year period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed squamous cell carcinoma of the head and neck planning to undergo curative-intent treatment.
Not a fit: Patients who are not planning to receive curative-intent surgery or radiation treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve monitoring for cancer relapse in head and neck cancer patients, leading to timely interventions.
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: 1. Participants must have histologically or cytologically confirmed squamous cell carcinoma of the head and neck mucosa and skin. 2. Participants must be age \>=18 years. 3. Participants must be planning to receive curative-intent surgery or radiation-based treatment as part of standard of care treatment. 4. Participants must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1\. Contraindication to phlebotomy for removal of 20 mL of peripheral blood each time point (up to 300 mL total over 15 time points).
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Jason W Chan, MD — University of California, San Francisco
- Study coordinator: Sonia Contreras Martinez
- Email: sonia.contrerasmartinez@ucsf.edu
- Phone: 415-514-6427
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.