ctDNA in Cutaneous Squamous Cell Carcinoma

Recruiting now

Conditions studied: Cutaneous Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID: NCT06875609
Run by: Massachusetts Eye and Ear Infirmary
People needed: 60
Starts: 2025-03-24
Expected to finish: 2029-04-30
Last updated by the study team: 2026-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Massachusetts Eye and Ear — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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