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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06606028
Status
Recruiting
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Conditions

  • Cutaneous Squamous Cell Carcinoma (CSCC)
  • Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)
  • Squamous Cell Carcinoma of Head and Neck
  • Squamous Cell Carcinoma of Skin

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blood Specimen Collection — PROCEDURE
    Approximately 20 mL of peripheral blood (10 mL per tube, x 3 Streck tubes) will be drawn at each time point
  • Tumor Tissue Collection — PROCEDURE
    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 — OTHER
    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

Study Details

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.

Key Dates

Start date
Oct 9, 2024
Status verified
Dec 2025
Primary completion
Dec 30, 2028
Completion
Dec 30, 2029

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Sonia Contreras Martinez
415-514-6427
[email protected]
877-827-3222
Jason W Chan, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of California, San Francisco· San Francisco, CA

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