Blood test to detect cancer recurrence in head and neck patients
Measurable Residual Disease Detection Using Tumor-Informed ctDNA Surveillance After Curative-Intent Treatment in HPV-Independent Squamous Cell Carcinoma of the Head and Neck
Massachusetts Eye and Ear Infirmary · NCT06744296
This study is testing a personalized blood test to see if it can help predict if head and neck cancer will come back after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts Eye and Ear Infirmary (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06744296 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of a personalized blood test in predicting recurrence of HPV-independent head and neck squamous cell carcinoma (HNSCC) after curative-intent treatment. It involves two arms: one for patients undergoing surgery and another for those receiving chemoradiotherapy. The study will measure minimal residual disease (MRD) through ctDNA analysis to differentiate between patients who will experience recurrence and those who will remain disease-free. A total of 75 patients will be followed for at least two years, with blood samples collected at various intervals for testing.
Who should consider this trial
Good fit: Ideal candidates are adults with newly diagnosed Stage III-IVB HPV-independent mucosal squamous cell carcinoma of the head and neck who are planning to undergo standard treatment.
Not a fit: Patients under 18 years old or those receiving non-standard therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enable earlier detection of cancer recurrence, allowing for timely intervention.
How similar studies have performed: Similar studies using ctDNA for cancer monitoring have shown promise, suggesting this approach could be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newly diagnosed AJCC 8th edition Stage III-IVB mucosal SCC of the head and neck, which includes tumors arising from the oral cavity, nasal cavity, paranasal sinuses, nasopharynx, oropharynx, hypopharynx, and larynx. * Available tissue for tumor-informed ctDNA panel creation. * Definitive treatment with standard of care surgery or chemoradiotherapy is planned to be administered at Massachusetts Eye and Ear Institute (MEEI) or within the Massachusetts General Hospital (MGH) Cancer Center (including but not limited to the Boston, Danvers, and Newton-Wellesley locations). Exclusion Criteria: * Patients \<18 years of age * Patients receiving non-standard of care therapy as determined by the clinical investigator * Participants who have undergone prior surgical resection, excisional biopsy, radiation, and/or chemotherapy for the treatment of HNSCC. Prior incisional biopsies are permitted. Discrepant cases will be reviewed by study PI. * Participants who are receiving any investigational agents at the time of enrollment. * Participants with AJCC Stage IVC HNSCC, which includes patients with biopsy-confirmed distant metastatic HNSCC, including but not limited to metastatic spread to the lungs, bones, or liver. * Active non-HNSCC malignancy. * Active pregnancy during treatment.
Where this trial is running
Boston, Massachusetts
- Massachusetts Eye and Ear — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Daniel Faden, MD — Massachusetts Eye and Ear
- Study coordinator: Michael Cheung, MSc, CCRP
- Email: mcheung0@meei.harvard.edu
- Phone: 617-573-6060
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.
Conditions: Squamous Cell Carcinoma of Head and Neck