Tumor-Informed ctDNA Testing of Head & Neck Intent Treatment of Squamous Cell Carcinoma
NCT ID: NCT06606028
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
200 participants
OBSERVATIONAL
2024-10-09
2029-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Blood Specimen Collection
Approximately 20 mL of peripheral blood (10 mL per tube, x 3 Streck tubes) will be drawn at each time point
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
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
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.
Blood Specimen Collection
Approximately 20 mL of peripheral blood (10 mL per tube, x 3 Streck tubes) will be drawn at each time point
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
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Blood Specimen Collection
Approximately 20 mL of peripheral blood (10 mL per tube, x 3 Streck tubes) will be drawn at each time point
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
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Participants must be age \>=18 years.
3. Participants must be planning to receive curative-intent surgery or radiation-based treatment as part of standard of care treatment.
4. Participants must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Haystack Oncology, Inc.
UNKNOWN
University of California, San Francisco
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jason W Chan, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California, San Francisco
San Francisco, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Sonia Contreras Martinez
Role: primary
[email protected]
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2024-07739
Identifier Type: REGISTRY
Identifier Source: secondary_id
232010
Identifier Type: -
Identifier Source: org_study_id