Cutaneous Squamous Cell CarcinomaNCT06875609
ctDNA in Cutaneous Squamous Cell Carcinoma
An observational study of Cutaneous Squamous Cell Carcinoma, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial summary
The purpose of this study is to test the potential for a liquid biopsy assay to detect residual disease after surgery in patients with cutaneous squamous cell carcinoma as well as the potential for this assay to monitor response to immunotherapy treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma
- What is being tested?
- Blood and Tissue Collection
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2025to 30 Apr 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: Patients ages 18 and older, who have been diagnosed with cutaneous squamous cell carcinoma (CSCC)
Who may be able to join
- Patients with surgically resectable primary CSCC with PNI (>0.1mm caliber nerve) or at least 2 high-risk features defined as size > 2cm, recurrent CSCC, LVI, immunosuppressed, poorly differentiated, and/or invasion >6mm/beyond subcutaneous fat;
- Patients with surgically resectable regional metastases not receiving neoadjuvant therapy
- Patients with resectable AJCC (8th ed) Stage II, III or IV(M0) CSCC treated with neoadjuvant immunotherapy as part of standard care.
- Patients with unresectable locally advanced or metastatic CSCC, AJCC (8th ed) Stage II, III, or IV), receiving immunotherapy as part of standard of care.
Who cannot join
- Patients with Cutaneous Squamous Cell Carcinoma not amenable to surgical resection
- Patients receiving or undergoing systemic therapies.
- Neoadjuvant Cohort
- Patients ineligible for neoadjuvant treatment.
- Definitive Immunotherapy Cohort
- Patients undergoing systemic therapies outside the standard of care or enrolled in conflicting clinical trials.
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
Massachusetts Eye and Ear
Boston, Massachusetts, 02114
Michael Cheung, MSc, CCRP, 617-573-6060, mcheung0@meei.harvard.edu
Sophia Shalhout, PhD
About this study
Official title: ctDNA Clearance and ctDNA Monitoring Study in Cutaneous Squamous Cell Carcinoma
The purpose of this study is to test the potential for a liquid biopsy assay to detect residual disease after surgery in patients with cutaneous squamous cell carcinoma as well as the potential for this assay to monitor response to immunotherapy treatment.
Read the detailed description
The study aims to better understand whether circulating tumor DNA, or ctDNA, a type of personalized blood test informed by the tumor, can help monitor recurrence and treatment responses in patients with cutaneous squamous cell carcinoma (CSCC), especially during and after treatment. Blood samples will be collected during regular treatment visits or through mobile phlebotomy visits, and analyzed to study how ctDNA levels change over time. Participants will be in the study for 2 years.
Circulating tumor DNA consists of small fragments of DNA shed into the bloodstream by cancer cells. It may serve as a non-invasive biomarker for detecting and monitoring CSCC, offering insights into tumor treatment response and/or progression. ctDNA can provide a "liquid biopsy," allowing real-time tracking of tumor dynamics. Specifically, the study is researching how ctDNA levels change in patients undergoing surgery, immunotherapy, or other standard treatments. The goal is to see if ctDNA can serve as a biomarker to better understand treatment response and detect potential progression/ recurrence of the cancer.
This study does not involve any experimental drugs or devices. All drugs and treatments administered to participants, including surgery and immunotherapy, are part of standard of care. The ctDNA blood test is being used as a research tool and is not currently approved by the U.S. Food and Drug Administration (FDA) for monitoring CSCC. The study aims to evaluate its potential future use as a reliable biomarker.
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Being tested
- Blood and Tissue Collection
- Keywords
- Circulating Tumor DNA, CSCC, Skin cancer, Biomarker, ctDNA, Minimal Residual Disease (MRD), Liquid Biopsy, Advanced Skin Cancer
- Medical subject headings
- Skin Neoplasms, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and Tissue CollectionDiagnostic test
Also called ctDNA test
Blood samples, and tissue samples will be collected from the participants, and used to determine whether circulating tumor DNA (ctDNA) testing can help monitor treatment in patients with CSCC, and to determine how ctDNA levels change in patients.
| Study group | Role | What they receive |
|---|---|---|
| Post-Operative Cohort | Cutaneous Squamous Cell Carcinoma cancer patients treated with surgery. Receives: Diagnostic Test: Blood and Tissue Collection | |
| Neoadjuvant Cohort | Cutaneous Squamous Cell Carcinoma patients treated with Neoadjuvant immunotherapy. Receives: Diagnostic Test: Blood and Tissue Collection | |
| Definitive Immunotherapy Cohort | Cutaneous Squamous Cell Carcinoma patients treated with definitive immunotherapy. Receives: Diagnostic Test: Blood and Tissue Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year recurrence-free survival (RFS) in patients with detectable vs no detectable ctDNA after surgery
To determine if there is an association between ctDNA clearance (defined as no detection of ctDNA) after surgical intervention and 2-year recurrence-free survival (RFS). The outcome will measure both ctDNA clearance (as a binary variable: detection or no detection) and RFS (measured in months). The association between these two outcomes will be analyzed as the primary outcome to determine if no detection of ctDNA is associated with longer RFS.
Measured: 24 Months
Neoadjuvant Cohort Primary Outcome: Response Monitoring
To evaluate ctDNA as a biomarker of response to neoadjuvant immunotherapy.
Measured: 24 Months
Definitive Treatment Cohort Primary Outcome
To evaluate whether ctDNA correlates with response to immunotherapy.
Measured: 24 Months
Secondary outcomes (2)
Post-Operative Cohort Secondary Outcome: Residual Free Survival (RFS) Surveillance over 2 Year
To evaluate RFS during the surveillance period, stratified by ctDNA test status over time to determine if ctDNA levels predict recurrence
Measured: 24 Months
Neoadjuvant Cohort Secondary Outcome: Correlation with Pathological Response
To evaluate if ctDNA correlates with pathological response to neoadjuvant therapy. This will help determine if ctDNA may one day be used to help risk stratify which patients need surgery after neoadjuvant immunotherapy.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start24 Mar 2025
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Squamous Cell CarcinomaStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Collaborators
- Haystack Oncology, Inc., Massachusetts General Hospital
- Responsible party
- Principal investigator, Sophia Shalhout, PhD, Massachusetts Eye and Ear Infirmary
- Investigators
- Sophia Z. Shalhout, PhD, Principal investigator, Massachusetts Eye and Ear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875609
- Sponsor's protocol ID
- 2024P003225
- Status last verified
- Mar 2026
- First submitted
- 10 Feb 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ctDNA Clearance and ctDNA Monitoring Study in Cutaneous Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06875609
- Acronym / sponsor ID
- 2024P003225
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Keywords
- Circulating Tumor DNA, CSCC, Skin cancer, Biomarker, ctDNA, Minimal Residual Disease (MRD), Liquid Biopsy, Advanced Skin Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Collaborators
- Haystack Oncology, Inc., Massachusetts General Hospital
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 13 Mar 2025 (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.
The purpose of this study is to test the potential for a liquid biopsy assay to detect residual disease after surgery in patients with cutaneous squamous cell carcinoma as well as the potential for this assay to monitor response to immunotherapy treatment.
Detailed description
The study aims to better understand whether circulating tumor DNA, or ctDNA, a type of personalized blood test informed by the tumor, can help monitor recurrence and treatment responses in patients with cutaneous squamous cell carcinoma (CSCC), especially during and after treatment. Blood samples will be collected during regular treatment visits or through mobile phlebotomy visits, and analyzed to study how ctDNA levels change over time. Participants will be in the study for 2 years.
Circulating tumor DNA consists of small fragments of DNA shed into the bloodstream by cancer cells. It may serve as a non-invasive biomarker for detecting and monitoring CSCC, offering insights into tumor treatment response and/or progression. ctDNA can provide a "liquid biopsy," allowing real-time tracking of tumor dynamics. Specifically, the study is researching how ctDNA levels change in patients undergoing surgery, immunotherapy, or other standard treatments. The goal is to see if ctDNA can serve as a biomarker to better understand treatment response and detect potential progression/ recurrence of the cancer.
This study does not involve any experimental drugs or devices. All drugs and treatments administered to participants, including surgery and immunotherapy, are part of standard of care. The ctDNA blood test is being used as a research tool and is not currently approved by the U.S. Food and Drug Administration (FDA) for monitoring CSCC. The study aims to evaluate its potential future use as a reliable biomarker.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Post-Operative Cohort | – | Diagnostic Test: Blood and Tissue CollectionCutaneous Squamous Cell Carcinoma cancer patients treated with surgery. |
| Neoadjuvant Cohort | – | Diagnostic Test: Blood and Tissue CollectionCutaneous Squamous Cell Carcinoma patients treated with Neoadjuvant immunotherapy. |
| Definitive Immunotherapy Cohort | – | Diagnostic Test: Blood and Tissue CollectionCutaneous Squamous Cell Carcinoma patients treated with definitive immunotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ages 18 and older, who have been diagnosed with cutaneous squamous cell carcinoma (CSCC)
Key inclusion criteria (4 listed)
- Patients with surgically resectable primary CSCC with PNI (>0.1mm caliber nerve) or at least 2 high-risk features defined as size > 2cm, recurrent CSCC, LVI, immunosuppressed, poorly differentiated, and/or invasion >6mm/beyond subcutaneous fat;
- Patients with surgically resectable regional metastases not receiving neoadjuvant therapy
- Patients with resectable AJCC (8th ed) Stage II, III or IV(M0) CSCC treated with neoadjuvant immunotherapy as part of standard care.
- Patients with unresectable locally advanced or metastatic CSCC, AJCC (8th ed) Stage II, III, or IV), receiving immunotherapy as part of standard of care.
Key exclusion criteria (6 listed)
- Patients with Cutaneous Squamous Cell Carcinoma not amenable to surgical resection
- Patients receiving or undergoing systemic therapies.
- Neoadjuvant Cohort
- Patients ineligible for neoadjuvant treatment.
- Definitive Immunotherapy Cohort
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 and Tissue CollectionAlso: ctDNA testBlood samples, and tissue samples will be collected from the participants, and used to determine whether circulating tumor DNA (ctDNA) testing can help monitor treatment in patients with CSCC, and to determine how ctDNA levels change in patients. | Diagnostic test | Definitive Immunotherapy Cohort, Neoadjuvant Cohort, Post-Operative Cohort |
Primary outcome
2-year recurrence-free survival (RFS) in patients with detectable vs no detectable ctDNA after surgery
Time frame: 24 Months
To determine if there is an association between ctDNA clearance (defined as no detection of ctDNA) after surgical intervention and 2-year recurrence-free survival (RFS). The outcome will measure both ctDNA clearance (as a binary variable: detection or no detection) and RFS (measured in months). The association between these two outcomes will be analyzed as the primary outcome to determine if no detection of ctDNA is associated with longer RFS.
Neoadjuvant Cohort Primary Outcome: Response Monitoring
Time frame: 24 Months
To evaluate ctDNA as a biomarker of response to neoadjuvant immunotherapy.
Definitive Treatment Cohort Primary Outcome
Time frame: 24 Months
To evaluate whether ctDNA correlates with response to immunotherapy.
2 secondary outcomes
Post-Operative Cohort Secondary Outcome: Residual Free Survival (RFS) Surveillance over 2 Year
Time frame: 24 Months
Neoadjuvant Cohort Secondary Outcome: Correlation with Pathological Response
Time frame: 24 Months
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 30 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Sophia Z. Shalhout, PhD principal investigator
Massachusetts Eye and Ear
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 Cutaneous Squamous Cell Carcinoma, run by Massachusetts Eye and Ear Infirmary 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 6 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 30 Mar 2026. 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 Michael Cheung, MSc, CCRP (6175736060, mcheung0@meei.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year recurrence-free survival (RFS) in patients with detectable vs no detectable ctDNA after surgery (time frame: 24 Months). The study lists 3 primary outcomes in all. 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 30 Mar 2026.