ctDNA in Cutaneous Squamous Cell Carcinoma

Launched by MASSACHUSETTS EYE AND EAR INFIRMARY · Mar 12, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to monitor patients with cutaneous squamous cell carcinoma (CSCC), a type of skin cancer, after they have had surgery. The researchers are testing a liquid biopsy, which is a simple blood test that can help detect any remaining cancer cells in the body. They want to see if this test can not only spot leftover disease after surgery but also track how well patients are responding to immunotherapy, a treatment that helps the immune system fight cancer.

To take part in this study, you need to have a specific type of CSCC that can be surgically removed, and you may have certain high-risk features that make your cancer more serious. For example, you might be eligible if your tumor is larger than 2 centimeters or if you've had a recurrence of CSCC. There are different groups in the trial for those who have had surgery, those receiving immunotherapy before surgery, and those receiving treatment for advanced cancer that cannot be surgically removed. If you join, you’ll have the chance to contribute to important research that could improve how we detect and treat this type of skin cancer in the future.

Gender

ALL

Eligibility criteria

• • 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.