Status:
RECRUITING
ctDNA in Cutaneous Squamous Cell Carcinoma
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Collaborating Sponsors:
Haystack Oncology, Inc.
Massachusetts General Hospital
Conditions:
Cutaneous Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Brief 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 th...
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 wi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
March 24 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06875609
Start Date
March 24 2025
End Date
April 30 2029
Last Update
March 26 2025
Active Locations (1)
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1
Massachusetts Eye and Ear
Boston, Massachusetts, United States, 02114