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

NCT06744296 | Recruiting

• 1 other identifier: 2024P002675
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Squamous Cell Carcinoma of Head and Neck

Outcome Measures

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

  2 weeks after treatment completion

Secondary Outcomes (3)

• 2 Years - Overall Survival (OS)

  2 weeks after treatment completion

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

  4 weeks after treatment completion

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

  6 week after treatment completion

Study Arms (2)

Patients Receiving only Surgery

Patients in this group will only be those who receive surgery, and does not receive radiographic testing or chemotherapy.

Other: Blood Draws and Tissue Sample(s)

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)

Other: Blood Draws and Tissue Sample(s)

Interventions

Blood Draws and Tissue Sample(s) OTHER

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

Patients Receiving only Surgery; Patients receiving chemoradiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead
• Haystack Oncology, Inc.: collaborator

Study Sites (1)

Massachusetts Eye and Ear

Boston, Massachusetts, 02114, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples and tissue ffpe samples

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Daniel Faden, MD

  Massachusetts Eye and Ear

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Cheung, MSc, CCRP

CONTACT

617-573-6060; mcheung0@meei.harvard.edu

Gyjstina Lumaj

CONTACT

glumaj@meei.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 20, 2024
• Study Start: February 3, 2025
• Primary Completion (Estimated): January 6, 2027
• Study Completion (Estimated): January 6, 2029
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

US (1)