Tumor-Informed ctDNA Testing for MRD Following Treatment of Squamous Cell Carcinoma

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Squamous Cell Carcinoma of Skin; Squamous Cell Carcinoma Head and Neck Cancer (HNSCC); Cutaneous Squamous Cell Carcinoma (CSCC); 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 squamous cell carcinomas (HNC) of the head and neck mucosa and skin 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: 250 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 mucosa and skin.
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

250 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