ctDNA in Cutaneous Squamous Cell Carcinoma
ctDNA Clearance and ctDNA Monitoring Study in Cutaneous Squamous Cell Carcinoma
Massachusetts Eye and Ear Infirmary
60 participants
Mar 24, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- Post-Operative Cohort
- 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.
Exclusion Criteria6
- 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.
Interventions
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.
Locations(1)
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NCT06875609