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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

Sponsor: Massachusetts Eye and Ear Infirmary · Participants: 60 · Started: Mar 24, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06875609

Locations in the U.S.

MassachusettsMassachusetts 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.