This study is not yet accepting patients

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

a study on Head and Neck Cancer Head and Neck Squamous Cell Carcinoma Squamous Cell Carcinoma Head and Neck Tumor Carcinoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Jason W Chan, MD
Headshot of Jason W Chan
Jason W Chan

Description

Summary

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.

Official Title

Tumor-informed ctDNA Testing for Minimal Residual Disease Monitoring Following Curative-intent Treatment of Squamous Cell Carcinoma of the Head and Neck

Details

PRIMARY OBJECTIVE:

  1. 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

Keywords

Squamous Cell Carcinoma of Head and Neck, ctDNA, Carcinoma, Squamous Cell Carcinoma, Blood Specimen Collection, Tumor Tissue Collection, Medical Record Review

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

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

Location

  • UCSF
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Jason W Chan, MD
    Dr. Jason Chan is a radiation oncologist who specializes in the treatment of head and neck, skull base, cutaneous, and thoracic malignancies. Dr. Chan received his undergraduate and medical degrees from Brown University. He completed his Internal Medicine internship at Kaiser Permanente San Francisco and his residency in Radiation Oncology at UCSF.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06606028
Study Type
Observational
Participants
Expecting 200 study participants
Last Updated