Recruiting

Tumor-Informed Testing

Sponsor:

UCLA

Code:

NCT06606028

Conditions

Squamous Cell Carcinoma of Head and Neck

Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)

Squamous Cell Carcinoma of Skin

Cutaneous Squamous Cell Carcinoma (CSCC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blood Specimen Collection

Tumor Tissue Collection

Medical Record Review

Study Details

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 squamous cell carcinomas (HNC) of the head and neck mucosa and skin after curative-intent primary radiation or surgery.

Conditions

Squamous Cell Carcinoma of Head and Neck

Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)

Squamous Cell Carcinoma of Skin

Cutaneous Squamous Cell Carcinoma (CSCC)

Study ID

NCT06606028

Start date

Oct 9, 2024

Status verified date

Dec, 2025

Completion date

Dec 30, 2029

Anticipated

Primary completion date

Dec 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort A: Non-investigational Radiation therapy

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.

Cohort B: Non-investigational Surgery

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.

Interventions

Blood Specimen Collection

Approximately 20 mL of peripheral blood (10 mL per tube, x 3 Streck tubes) will be drawn at each time point

Tumor Tissue Collection

Formalin-fixed paraffin embedded tumor tissue samples (tissue blocks of 12 x 10 millimeter (mm) unstained slides) derived from biopsy or surgical resection will be collected at screening

Medical Record Review

Medical records will be reviewed to collect standard of care p16 staining by immunohistochemistry and/or high-risk human papillomavirus (HPV) DNA or RNA testing that is performed as part of standard of care

Primary outcome measure

  • Cumulative incidence rate of ctDNA [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Sonia Contreras Martinez

415-514-6427sonia.contrerasmartinez@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Sonia Contreras Martinez

415-514-6427

sonia.contrerasmartinez@ucsf.edu

877-827-3222cancertrials@ucsf.edu

Principal Investigator:

Jason W Chan, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Dec 12, 2025

Last verified

Dec, 2025

Keywords

  • ctDNA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-12-12.