Squamous Cell Carcinoma of Head and NeckNCT06606028
Tumor-Informed ctDNA Testing for MRD Following Treatment of Squamous Cell Carcinoma
An observational study of Squamous Cell Carcinoma of Head and Neck and Squamous Cell Carcinoma Head and Neck Cancer (HNSCC), run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck, Squamous Cell Carcinoma Head and Neck Cancer (HNSCC), Squamous Cell Carcinoma of Skin
- What is being tested?
- Blood Specimen Collection, Tumor Tissue Collection and Medical Record Review
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2024to 30 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with squamous cell carcinoma of the head and neck mucosa and skin.
Who may be able to join
- 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.
Who cannot join
- 1. Contraindication to phlebotomy for removal of 20 mL of peripheral blood each time point (up to 300 mL total over 15 time points).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Sonia Contreras Martinez, 415-514-6427
sonia.contrerasmartinez@ucsf.edu, 877-827-3222, cancertrials@ucsf.edu
About this study
Official title: Tumor-informed ctDNA Testing for Minimal Residual Disease Monitoring Following Curative-intent Treatment of Squamous Cell Carcinoma of the Head and Neck.
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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
- 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)
- Being tested
- Blood Specimen Collection, Tumor Tissue Collection, Medical Record Review
- Keywords
- ctDNA
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Specimen CollectionProcedure or surgery
Also called Blood Specimen, Biospecimen collection
Approximately 20 mL of peripheral blood (10 mL per tube, x 3 Streck tubes) will be drawn at each time point
Tumor Tissue CollectionProcedure or surgery
Also called Tissue Specimen, Biospecimen 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 ReviewOther
Also called Chart 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Blood Specimen Collection; Procedure: Tumor Tissue Collection; Other: Medical Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Secondary outcomes (5)
Proportion of participants at diagnosis with a positive (non-zero) ctDNA result.
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.
Measured: Up to 2 years
Association of association of quantitative ctDNA levels with overall survival (OS)
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).
Measured: Up to 2 years
Association of association of quantitative ctDNA levels with disease-free survival (DFS)
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).
Measured: Up to 2 years
Association of association of quantitative ctDNA levels with time to recurrence (TTR)
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.
Measured: Up to 2 years
Association of quantitative ctDNA levels with follow-up imaging tumor volume.
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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start9 Oct 2024
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Haystack Oncology, Inc.
- Responsible party
- Sponsor
- Investigators
- Jason W Chan, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606028
- Sponsor's protocol ID
- 232010
- Other IDs
- NCI-2024-07739
- Status last verified
- Dec 2025
- First submitted
- 18 Sep 2024
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified laboratory data will be shared with industry collaborators on this study only
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor-informed ctDNA Testing for Minimal Residual Disease Monitoring Following Curative-intent Treatment of Squamous Cell Carcinoma of the Head and Neck.
- ClinicalTrials.gov ID
- NCT06606028
- Acronym / sponsor ID
- 232010
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Haystack Oncology, Inc.
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Non-investigational Radiation therapy | – | Procedure: Blood Specimen Collection, Procedure: Tumor Tissue Collection, Other: Medical Record ReviewParticipants 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. |
| Cohort B: Non-investigational Surgery | – | Procedure: Blood Specimen Collection, Procedure: Tumor Tissue Collection, Other: Medical Record ReviewParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with squamous cell carcinoma of the head and neck mucosa and skin.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Contraindication to phlebotomy for removal of 20 mL of peripheral blood each time point (up to 300 mL total over 15 time points).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Specimen CollectionAlso: Blood Specimen, Biospecimen collectionApproximately 20 mL of peripheral blood (10 mL per tube, x 3 Streck tubes) will be drawn at each time point | Procedure or surgery | Cohort A: Non-investigational Radiation therapy, Cohort B: Non-investigational Surgery |
| Tumor Tissue CollectionAlso: Tissue Specimen, Biospecimen collectionFormalin-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 | Procedure or surgery | Cohort A: Non-investigational Radiation therapy, Cohort B: Non-investigational Surgery |
| Medical Record ReviewAlso: Chart ReviewMedical 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 | Cohort A: Non-investigational Radiation therapy, Cohort B: Non-investigational Surgery |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No. De-identified laboratory data will be shared with industry collaborators on this study only
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason W Chan, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Squamous Cell Carcinoma of Head and Neck and Squamous Cell Carcinoma Head and Neck Cancer (HNSCC), run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sonia Contreras Martinez (415-514-6427, sonia.contrerasmartinez@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence rate of ctDNA (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.