RecruitingNot Applicable

ctDNA in Cutaneous Squamous Cell Carcinoma

United States60 participantsStarted 2025-03-24

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Post-Operative Cohort Inclusion Criteria: * 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 Exclusion Criteria: * Patients with Cutaneous Squamous Cell Carcinoma not amenable to surgical resection * Patients receiving or undergoing systemic therapies. Neoadjuvant Cohort Inclusion Criteria: * Patients with resectable AJCC (8th ed) Stage II, III or IV(M0) CSCC treated with neoadjuvant immunotherapy as part of standard care. Exclusion Criteria: * Patients ineligible for neoadjuvant treatment. Definitive Immunotherapy Cohort Inclusion Criteria: * Patients with unresectable locally advanced or metastatic CSCC, AJCC (8th ed) Stage II, III, or IV), receiving immunotherapy as part of standard of care. Exclusion Criteria: * Patients undergoing systemic therapies outside the standard of care or enrolled in conflicting clinical trials.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

2-year recurrence-free survival (RFS) in patients with detectable vs no detectable ctDNA after surgery

Timeframe: 24 Months

Neoadjuvant Cohort Primary Outcome: Response Monitoring

Timeframe: 24 Months

Definitive Treatment Cohort Primary Outcome

Timeframe: 24 Months

Trial details

NCT IDNCT06875609

SponsorMassachusetts Eye and Ear Infirmary

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-04-30

Contact for this trial

Michael Cheung, MSc, CCRP

6175736060 mcheung0@meei.harvard.edu

View on ClinicalTrials.gov More Cutaneous Squamous Cell Carcinoma trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.