Tumor-Informed ctDNA Testing for MRD Following Treatment of Squamous Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood Specimen Collection, Tumor Tissue Collection, Medical Record Review.
- Who it may be relevant to
- Registry 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). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Tumor-informed ctDNA Testing for Minimal Residual Disease Monitoring Following Curative-intent Treatment of Squamous Cell Carcinoma of the Head and Neck.
Overview
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.
Detailed description
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:
1. To describe the prevalence of detectable ctDNA at initial diagnosis in participants with HNC. 2. 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)). 3. 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
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
Primary outcome measures
- Cumulative incidence rate of ctDNA [Time frame: Up to 2 years]
Secondary outcome measures (5)
- Proportion of participants at diagnosis with a positive (non-zero) ctDNA result. [Time frame: Up to 2 years]
- Association of association of quantitative ctDNA levels with overall survival (OS) [Time frame: Up to 2 years]
- Association of association of quantitative ctDNA levels with disease-free survival (DFS) [Time frame: Up to 2 years]
- Association of association of quantitative ctDNA levels with time to recurrence (TTR) [Time frame: Up to 2 years]
- Association of quantitative ctDNA levels with follow-up imaging tumor volume. [Time frame: Up to 2 years]
Eligibility criteria
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
1\. Contraindication to phlebotomy for removal of 20 mL of peripheral blood each time point (up to 300 mL total over 15 time points).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of California, San Francisco — San Francisco
Identifiers
NCT: NCT06606028 · 232010 · NCI-2024-07739