Measurable Residual Disease Detection Using Tumor-Informed ctDNA Surveillance After Curative-Intent Treatment in HPV-Independent Squamous Cell Carcinoma of the Head and Neck

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts Eye and Ear Infirmary
Study ID
NCT06744296
Status
Recruiting
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Conditions

  • Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blood Draws and Tissue Sample(s) — OTHER
    All participants on the study, regardless of arm, will be getting blood draws, and tissue samples.

Study Details

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.

Key Dates

Start date
Feb 3, 2025
Status verified
May 2025
Primary completion
Jan 6, 2027
Completion
Jan 6, 2029

Study Design

Enrollment
75 participants (estimated)

Arms

  • Arm: Patients Receiving only Surgery
    Patients in this group will only be those who receive surgery, and does not receive radiographic testing or chemotherapy.
  • Arm: Patients receiving chemoradiotherapy
    * 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)

Primary Outcome Measure

2 Years - Disease Free Survival (DFS) [ Time Frame: 2 weeks after treatment completion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts Eye and EarBostonMassachusetts02114
Michael Cheung, MSc, CCRP
[email protected]
617-573-6060
Gjystina Lumaj
[email protected]
Daniel Faden, MD (PRINCIPAL_INVESTIGATOR)

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