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Tumor-Informed ctDNA Testing of Head & Neck Intent Treatment of Squamous Cell Carcinoma

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Enrolling

Conditions

Squamous Cell Carcinoma of Head and Neck

Treatments

Procedure: Tumor Tissue Collection
Other: Medical Record Review
Procedure: Blood Specimen Collection

Study type

Observational

Funder types

Other

Identifiers

NCT06606028
NCI-2024-07739 (Registry Identifier)
232010

Details and patient eligibility

About

This is a single-center, non-interventional, observational study that evaluates the correlation of circulating tumor DNA (ctDNA) testing to cancer relapse for participants with head and neck squamous cell carcinomas (HNC) after curative-intent primary radiation or surgery.

Full description

PRIMARY OBJECTIVE:

I. To determine the rates of detectable ctDNA within two years of participants treated with curative-intent surgery or radiation-based treatment for HNC.

SECONDARY OBJECTIVES:

  1. To describe the prevalence of detectable ctDNA at initial diagnosis in participants with HNC.
  2. To describe the association of quantitative ctDNA levels with time-to-event outcomes (overall survival (OS), disease-free survival (DFS), and time to recurrence (TTR)).
  3. To describe the association of quantitative ctDNA levels with follow-up imaging tumor volume.

OUTLINE:

Participants will have tissue samples collected at screening and blood samples collected for analysis before, during, and after non-investigational, standard of care treatment for cancer for up to 2 years

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Participants must have histologically or cytologically confirmed squamous cell carcinoma of the head and neck.
  2. Participants must be age >=18 years.
  3. Participants must be planning to receive curative-intent surgery or radiation-based treatment as part of standard of care treatment.
  4. Participants must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

  1. Contraindication to phlebotomy for removal of 20 mL of peripheral blood each time point (up to 300 mL total over 15 time points).

Trial design

200 participants in 2 patient groups

Cohort A: Non-investigational Radiation therapy
Description:
Participants will have tumor tissue collected at screening and blood samples (approximately 20ml x 3) will be obtained during non-investigational, standard of care radiation and after care for up to 2 years.
Treatment:
Procedure: Blood Specimen Collection
Other: Medical Record Review
Procedure: Tumor Tissue Collection
Cohort B: Non-investigational Surgery
Description:
Participants will have tumor tissue collected at screening and blood samples (approximately 20ml x 3) will be obtained during non-investigational, standard of care surgery and after care for up to 2 years.
Treatment:
Procedure: Blood Specimen Collection
Other: Medical Record Review
Procedure: Tumor Tissue Collection

Trial contacts and locations

1

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Central trial contact

Jamese Johnson

Data sourced from clinicaltrials.gov

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