Recruiting

CtDNA Surveillance

Sponsor:

Massachusetts Eye and Ear Infirmary

Code:

NCT06744296

Conditions

Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blood Draws and Tissue Sample(s)

Study Details

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

Study ID

NCT06744296

Start date

Feb 3, 2025

Status verified date

May, 2025

Completion date

Jan 6, 2029

Anticipated

Primary completion date

Jan 6, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients Receiving only Surgery

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

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)

Interventions

Blood Draws and Tissue Sample(s)

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Michael Cheung, MSc, CCRP

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

Gyjstina Lumaj

glumaj@meei.harvard.edu

Locations

Massachusetts Eye and Ear

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Michael Cheung, MSc, CCRP

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

Gjystina Lumaj

glumaj@meei.harvard.edu

Principal Investigator:

Daniel Faden, MD

More Information

Sponsor

Massachusetts Eye and Ear Infirmary

Last update posted

May 18, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts Eye and Ear Infirmary on 2025-05-18.