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ctDNA in Cutaneous Squamous Cell Carcinoma
RecruitingObservational study
ctDNA Clearance and ctDNA Monitoring Study in Cutaneous Squamous Cell Carcinoma
Who can join
Ages 18 and older · All sexes
Full 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.
About the study
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.
What is being tested
- Blood and Tissue Collection (diagnostic test)
Sponsor: Massachusetts Eye and Ear Infirmary · Participants: 60 · Started: Mar 24, 2025
Contact the study team
- Michael Cheung, MSc, CCRP · Phone: 6175736060
Official record on ClinicalTrials.gov — NCT06875609
Locations in the U.S.
| Massachusetts | Massachusetts Eye and Ear, Boston |
Conditions
From ClinicalTrials.gov, data retrieved Oct 3, 2026. Each study sets its own eligibility; the study team decides who can join.