Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06606028

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Squamous Cell Carcinoma of Head and Neck Carcinoma Carcinoma, Squamous Cell Cutaneous Squamous Cell Carcinoma (CSCC) Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma Head and Neck Cancer (HNSCC) Squamous Cell Carcinoma of Skin

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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:

  • To describe the prevalence of detectable ctDNA at initial diagnosis in participants with HNC.
  • 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)).
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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

Other names: Blood Specimen, Biospecimen collection

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

Other names: Tissue Specimen, Biospecimen collection

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

Other names: Chart Review

Primary outcomes

  1. Cumulative incidence rate of ctDNA

    Time frame: Up to 2 years

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

Secondary outcomes

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

    Time frame: Up to 2 years

    The prevalence of detectable ctDNA at initial diagnosis in participants with locally-advanced head and neck cancer will be reported as the proportion of participants at diagnosis with a positive (non-zero) ctDNA result.

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

    Time frame: Up to 2 years

    The Spearman's correlation coefficient (rs) measures the strength and direction of association between two variables. The Spearman correlation coefficient, rs, can take values from +1 to -1 where a value of +1 indicates a perfect association, an rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association. This correlation will be used to determine the association of quantitative ctDNA levels with overall survival (OS).

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

    Time frame: Up to 2 years

    The Spearman's correlation coefficient (rs) measures the strength and direction of association between two variables. The Spearman correlation coefficient, rs, can take values from +1 to -1 where a value of +1 indicates a perfect association, an rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association. This correlation will be used to determine the association of quantitative ctDNA levels with overall survival (OS).

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

    Time frame: Up to 2 years

    The Pearson correlation coefficient (r) measures the strength and direction of association between two variables. The Pearson correlation coefficient (r) can take values from +1 to -1 where a value of +1 indicates a perfect association, a value of 0 indicates no association, and a value of -1 indicates a perfect negative association. The closer r is to 0, the weaker the association. This correlation will be used to determine the association of quantitative ctDNA levels with TTR.

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

    Time frame: Up to 2 years

    The Pearson correlation coefficient (r) measures the strength and direction of association between two variables. The Pearson correlation coefficient (r) can take values from +1 to -1 where a value of +1 indicates a perfect association, a value of 0 indicates no association, and a value of -1 indicates a perfect negative association. The closer r is to 0, the weaker the association. This correlation will be used to determine the association of quantitative ctDNA levels with tumor volume.

Study contacts

Contact information is provided by the study sponsor or research team.

Sonia Contreras Martinez

CONTACT

[email protected]

415-514-6427

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Haystack Oncology, Inc.

Registry information

Official study title

Tumor-informed ctDNA Testing for Minimal Residual Disease Monitoring Following Curative-intent Treatment of Squamous Cell Carcinoma of the Head and Neck.

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Sep 20, 2024
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.