RECRUITING

Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma

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Conditions

Head and Neck NeoplasmCarcinoma, Squamous CellSquamous Cell CarcinomaCirculating Tumor DNA

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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

Circulating tumor DNA (ctDNA) is a blood-based test that measures dying or dead cancer cells that are already circulating in the blood. In this study, the investigators will enroll patients who are planning to receive surgery to remove their head and neck cancer. The investigators are interested to learn how ctDNA levels change with surgery and over the course of time. The investigators also want to determine if there are certain features of the tumor or the patient themselves that might cause ctDNA to be higher than other patients. Also, the investigators want to explore if the detection of ctDNA following surgery is related to cancer recurrence.

Official Title

Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma

Quick Facts

Study Start:2020-01-14
Study Completion:2026-02-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04099290

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. * Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Consent for the use of any residual material from biopsy and/or surgical resection (archival tissue) and serial blood draws will be required for enrollment.
  2. * Age ≥ 18 years of age on day of signing informed consent
  3. * Newly diagnosed, histologically confirmed squamous cell carcinoma of the head and neck, including the following subtypes: oral cavity, oropharynx, larynx
  4. * Must be planning to undergo gross total resection of the primary tumor with curative intent at UNC-CH hospital
  5. * No prior, definitive therapy to primary tumor. Must meet one of the following clinical stages: T3-T4 (if T1/T2 must have nodal involvement), Any N, M0
  6. * Patient must be amenable to receiving adjuvant therapy with radiotherapy +/- systemic therapy, as clinically indicated, based on either standard of care (SOC) or appropriate clinical trial.
  7. * Diagnostic tumor material must be available for correlative analysis
  8. * Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee
  1. * Has known evidence of metastatic disease based on clinical or radiographic studies
  2. * Women who are pregnant or nursing
  3. * History of another primary malignancy in the last 5 years prior to registration. Patients with history of in situ cancer or basal or localized squamous cell skin cancers are eligible.
  4. * Patients with primary skin cancers of the head and neck, including basal or squamous cell cancers
  5. * Prior chemotherapy, IP, biologic, or hormonal therapy for HNSCC treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.

Contacts and Locations

Study Contact

Siddharth Sheth, MD
CONTACT
(919) 966-3856
Siddharth.Sheth@unchealth.unc.edu
Rebecca Green, MSW
CONTACT
(984) 974-8440
rlgreen@med.unc.edu

Principal Investigator

Siddharth Sheth, MD
PRINCIPAL_INVESTIGATOR
UNC Health Care
Gaorav Gupta, MD
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill

Study Locations (Sites)

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

  • Siddharth Sheth, MD, PRINCIPAL_INVESTIGATOR, UNC Health Care
  • Gaorav Gupta, MD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

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 Date2020-01-14
Study Completion Date2026-02-02

Study Record Updates

Study Start Date2020-01-14
Study Completion Date2026-02-02

Terms related to this study

Keywords Provided by Researchers

  • Squamous Cell Carcinoma
  • Circulating Tumor DNA

Additional Relevant MeSH Terms

  • Head and Neck Neoplasm
  • Carcinoma, Squamous Cell