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

NCT ID: NCT06744296

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-03
• Study Completion Date: 2029-01-06

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.

Detailed Description

This is a two-arm, prospective, observational study of patients with human papillomavirus (HPV)-independent head and neck squamous cell carcinoma (HNSCC) who are receiving curative-intent treatment. Arm 1 will consist of patients who undergo surgery. Arm 2 will consist of patients who undergo chemoradiotherapy.

The study will test the following hypotheses:

1. That applying a tumor-informed minimal residual disease (MRD) assay after completion of curative-intent treatment will accurately discriminate between patients who will eventually experience recurrence (those are MRD positive) and patients who will remain disease-free (those who are MRD negative). The hypothesis is that patients who have detectable ctDNA following treatment-MRD positive patients-will experience recurrent disease within 2 years, while patients who have no detectable ctDNA-MRD negative patients-will remain disease free at 2 years.

2. That measuring MRD after completion of curative-intent treatment will provide a lead time from detectable to clinical diagnosis of recurrent disease of at least 3 months.

The primary outcome is 2-year DFS in patients with detectable vs no detectable ctDNA two weeks after treatment completion.

The study will accrue 75 patients, who will be followed for a minimum of 2 years.

Subjects will have blood draws before, during and following treatment at regular intervals for testing with the assay (Haystack MRD™)

Conditions

Squamous Cell Carcinoma of Head and Neck

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients Receiving only Surgery

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

Blood Draws and Tissue Sample(s)

Intervention Type: OTHER

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

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)

Blood Draws and Tissue Sample(s)

Intervention Type: OTHER

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

Interventions

Blood Draws and Tissue Sample(s)

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haystack Oncology, Inc.

UNKNOWN

Sponsor Role: collaborator

Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role: lead

Responsible Party

Daniel L. Faden, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Faden, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Eye and Ear

Locations

Massachusetts Eye and Ear

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael Cheung, MSc, CCRP

Role: CONTACT

mcheung0@meei.harvard.edu

617-573-6060

Gyjstina Lumaj

Role: CONTACT

glumaj@meei.harvard.edu

Facility Contacts

Michael Cheung, MSc, CCRP

Role: primary

mcheung0@meei.harvard.edu

617-573-6060

Gjystina Lumaj

Role: backup

glumaj@meei.harvard.edu

Other Identifiers

2024P002675

Identifier Type: -

Identifier Source: org_study_id