ctDNA in Cutaneous Squamous Cell Carcinoma
ConditionCutaneous Squamous Cell Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMassachusetts Eye and Ear Infirmary
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Patients with Cutaneous Squamous Cell Carcinoma not amenable to surgical resection
Patients receiving or undergoing systemic therapies.
Patients with resectable AJCC (8th ed) Stage II, III or IV(M0) CSCC treated with neoadjuvant immunotherapy as part of standard care.
Patients ineligible for neoadjuvant treatment.
Trial design
Treatments tested in this trial
- Blood and Tissue Collection
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
Massachusetts Eye and Ear Infirmary
Lead sponsor
Haystack Oncology, Inc.
Collaborator
Massachusetts General Hospital
Collaborator
Source ClinicalTrials.gov