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

ConditionSquamous Cell Carcinoma of Head and Neck
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMassachusetts Eye and Ear Infirmary

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial population

Patients with Stage III-IVB mucosal squamous cell carcinoma of the head and neck

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood Draws and Tissue Sample(s)

    Other intervention

    All participants on the study, regardless of arm, will be getting blood draws, and tissue samples.

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: Patients Receiving only Surgery1 intervention
Group B: Patients receiving chemoradiotherapy1 intervention

Trial outcomes

Primary outcomes

1

2 Years - Disease Free Survival (DFS)

2-year disease-free survival (DFS) in patients with detectable vs no detectable ctDNA two weeks after treatment completion

Time frame
2 weeks after treatment completion

Secondary outcomes

1

2 Years - Overall Survival (OS)

2-year overall survival (OS) in patients with detectable vs no detectable ctDNA two weeks after treatment completion

Time frame
2 weeks after treatment completion
2

2 Years - Disease Free Survival (DFS) and Overall Survival (OS)

2-year disease-free survival (DFS) and overall survival (OS) in patients with detectable vs no detectable ctDNA four weeks after treatment completion

Time frame
4 weeks after treatment completion
3

2 - Years Disease Free Survival (DFS) and Overall Survival (OS)

2-year disease-free survival (DFS) and overall survival (OS) in patients with detectable vs no detectable ctDNA six weeks after treatment completion

Time frame
6 week after treatment completion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts Eye and Ear Infirmary

Lead sponsor

Massachusetts General Hospital

Sponsor institution

Haystack Oncology, Inc.

Collaborator

Source ClinicalTrials.gov
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