Clinical trial NCT06606028: Tumor-Informed ctDNA Testing of Head & Neck Intent Treatment of Squamous Cell Carcinoma
Official title: Tumor-informed ctDNA Testing for Minimal Residual Disease Monitoring Following Curative-intent Treatment of Squamous Cell Carcinoma of the Head and Neck
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Squamous Cell Carcinoma of Head and Neck
Keywords: ctDNA
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Haystack Oncology, Inc.
First posted: 2024-09-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with squamous cell carcinoma of the head and neck mucosa.

Brief 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.

Detailed 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

Eligibility criteria: 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).

Primary outcomes:
measure: Cumulative incidence rate of ctDNA
timeFrame: Up to 2 years
Secondary outcomes:
measure: Proportion of participants at diagnosis with a positive (non-zero) ctDNA result.
timeFrame: Up to 2 years
measure: Association of association of quantitative ctDNA levels with overall survival (OS)
timeFrame: Up to 2 years
measure: Association of association of quantitative ctDNA levels with disease-free survival (DFS)
timeFrame: Up to 2 years
measure: Association of association of quantitative ctDNA levels with time to recurrence (TTR)
timeFrame: Up to 2 years
measure: Association of quantitative ctDNA levels with follow-up imaging tumor volume.
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jason W Chan, MD
role: PRINCIPAL_INVESTIGATOR
References: