ctDNA in Cutaneous Squamous Cell Carcinoma

Recruiting

• Conditions: Cutaneous Squamous Cell Carcinoma

• Registration Number: NCT06875609
• Lead Sponsor: Massachusetts Eye and Ear Infirmary

Brief Summary

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.

Detailed Description

The study aims to better understand whether circulating tumor DNA, or ctDNA, a type of personalized blood test informed by the tumor, can help monitor recurrence and treatment responses in patients with cutaneous squamous cell carcinoma (CSCC), especially during and after treatment. Blood samples will be collected during regular treatment visits or through mobile phlebotomy visits, and analyzed to study how ctDNA levels change over time. Participants will be in the study for 2 years.

Circulating tumor DNA consists of small fragments of DNA shed into the bloodstream by cancer cells. It may serve as a non-invasive biomarker for detecting and monitoring CSCC, offering insights into tumor treatment response and/or progression. ctDNA can provide a "liquid biopsy," allowing real-time tracking of tumor dynamics. Specifically, the study is researching how ctDNA levels change in patients undergoing surgery, immunotherapy, or other standard treatments. The goal is to see if ctDNA can serve as a biomarker to better understand treatment response and detect potential progression/ recurrence of the cancer.

This study does not involve any experimental drugs or devices. All drugs and treatments administered to participants, including surgery and immunotherapy, are part of standard of care. The ctDNA blood test is being used as a research tool and is not currently approved by the U.S. Food and Drug Administration (FDA) for monitoring CSCC. The study aims to evaluate its potential future use as a reliable biomarker.

Study Timeline

• Study First Submitted: 2025-02-10
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-12
• Study Start: 2025-03-24
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-26
• Primary Completion: 2028-04-30
• Study Completion: 2029-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2-year recurrence-free survival (RFS) in patients with detectable vs no detectable ctDNA after surgery	24 Months	To determine if there is an association between ctDNA clearance (defined as no detection of ctDNA) after surgical intervention and 2-year recurrence-free survival (RFS). The outcome will measure both ctDNA clearance (as a binary variable: detection or no detection) and RFS (measured in months). The association between these two outcomes will be analyzed as the primary outcome to determine if no detection of ctDNA is associated with longer RFS.
Neoadjuvant Cohort Primary Outcome: Response Monitoring	24 Months	To evaluate ctDNA as a biomarker of response to neoadjuvant immunotherapy.
Definitive Treatment Cohort Primary Outcome	24 Months	To evaluate whether ctDNA correlates with response to immunotherapy.

Secondary Outcome Measures

Name	Time	Method
Post-Operative Cohort Secondary Outcome: Residual Free Survival (RFS) Surveillance over 2 Year	24 Months	To evaluate RFS during the surveillance period, stratified by ctDNA test status over time to determine if ctDNA levels predict recurrence
Neoadjuvant Cohort Secondary Outcome: Correlation with Pathological Response	24 Months	To evaluate if ctDNA correlates with pathological response to neoadjuvant therapy. This will help determine if ctDNA may one day be used to help risk stratify which patients need surgery after neoadjuvant immunotherapy.

Trial Locations

Locations (1)

Massachusetts Eye and Ear; 🇺🇸 Boston, Massachusetts, United States