Clinical trial · Observational
Measurable Residual Disease Detection Using Tumor-Informed ctDNA Surveillance After Curative-Intent Treatment in HPV-Independent Squamous Cell Carcinoma of the Head and Neck
NCT06744296CI-TRIAL-00089858MRD-DUCHESSrecruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study will test the ability of a personalized blood test to determine which head and neck cancer patients will have a recurrence after treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Draws and Tissue Sample(s) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Patients Receiving only Surgery
- description
- Patients in this group will only be those who receive surgery, and does not receive radiographic testing or chemotherapy.
- interventionNames
- Other: Blood Draws and Tissue Sample(s)
- label
- Patients receiving chemoradiotherapy
- description
- * 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 (arm 1) or chemoradiotherapy (arm 2)
- interventionNames
- Other: Blood Draws and Tissue Sample(s)
Primary outcomes (1)
- measure
- 2 Years - Disease Free Survival (DFS)
- timeFrame
- 2 weeks after treatment completion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.