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

NCT06606028 | Recruiting DMC

• 2 other identifiers: 232010NCI-2024-07739
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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)

Keywords

ctDNA

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence rate of ctDNA

  Cumulative incidence will be estimated by evaluating the cumulative incidence of positive ctDNA (non-zero) with death as a competing risk.

  Up to 2 years

Secondary Outcomes (5)

• Proportion of participants at diagnosis with a positive (non-zero) ctDNA result.

  Up to 2 years

• Association of association of quantitative ctDNA levels with overall survival (OS)

  Up to 2 years

• Association of association of quantitative ctDNA levels with disease-free survival (DFS)

  Up to 2 years

• Association of association of quantitative ctDNA levels with time to recurrence (TTR)

  Up to 2 years

• Association of quantitative ctDNA levels with follow-up imaging tumor volume.

  Up to 2 years

Study Arms (2)

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.

Procedure: Blood Specimen Collection; Procedure: Tumor Tissue Collection; Other: Medical Record Review

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.

Procedure: Blood Specimen Collection; Procedure: Tumor Tissue Collection; Other: Medical Record Review

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

Also known as: Blood Specimen, Biospecimen collection

Cohort A: Non-investigational Radiation therapy; Cohort B: Non-investigational Surgery

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

Also known as: Tissue Specimen, Biospecimen collection

Cohort A: Non-investigational Radiation therapy; Cohort B: Non-investigational Surgery

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

Also known as: Chart Review

Cohort A: Non-investigational Radiation therapy; Cohort B: Non-investigational Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with squamous cell carcinoma of the head and neck mucosa and skin.

You may qualify if:

• Participants must have histologically or cytologically confirmed squamous cell carcinoma of the head and neck mucosa and skin.
• Participants must be age \>=18 years.
• Participants must be planning to receive curative-intent surgery or radiation-based treatment as part of standard of care treatment.
• Participants must have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• \. Contraindication to phlebotomy for removal of 20 mL of peripheral blood each time point (up to 300 mL total over 15 time points).

Sponsors & Collaborators

• University of California, San Francisco: lead
• Haystack Oncology, Inc.: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue and blood samples

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Interventions

Blood Specimen Collection; Histocompatibility Testing

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Immunologic Tests; Immunologic Techniques

Study Officials

• Jason W Chan, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonia Contreras Martinez

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 20, 2024
• Study Start: October 9, 2024
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2029
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)