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

NCT06606028 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2025-12-12

No results posted yet for this study

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)

Interventions

PROCEDURE

Blood Specimen Collection

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

PROCEDURE

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

OTHER

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

Sponsors & Collaborators

Principal Investigators

  • Jason W Chan, MD · University of California, San Francisco

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-09
Primary Completion
2028-12-30
Completion
2029-12-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06606028 on ClinicalTrials.gov