RECRUITING

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

Talk to us

Conditions

Squamous Cell Carcinoma of Head and Neck

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-03
Study Completion:2029-01-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06744296

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Available tissue for tumor-informed ctDNA panel creation.
  3. * 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).
  1. * Patients \<18 years of age
  2. * Patients receiving non-standard of care therapy as determined by the clinical investigator
  3. * 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.
  4. * Participants who are receiving any investigational agents at the time of enrollment.
  5. * 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.
  6. * Active non-HNSCC malignancy.
  7. * Active pregnancy during treatment.

Contacts and Locations

Study Contact

Michael Cheung, MSc, CCRP
CONTACT
617-573-6060
mcheung0@meei.harvard.edu
Gyjstina Lumaj
CONTACT
glumaj@meei.harvard.edu

Principal Investigator

Daniel Faden, MD
PRINCIPAL_INVESTIGATOR
Massachusetts Eye and Ear

Study Locations (Sites)

Massachusetts Eye and Ear
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts Eye and Ear Infirmary

  • Daniel Faden, MD, PRINCIPAL_INVESTIGATOR, Massachusetts Eye and Ear

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-03
Study Completion Date2029-01-06

Study Record Updates

Study Start Date2025-02-03
Study Completion Date2029-01-06

Terms related to this study

Additional Relevant MeSH Terms

  • Squamous Cell Carcinoma of Head and Neck