ctDNA in Cutaneous Squamous Cell Carcinoma

NCT06875609 | Recruiting

• 1 other identifier: 2024P003225
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Squamous Cell Carcinoma

Keywords

Circulating Tumor DNA; CSCC; Skin cancer; Biomarker; ctDNA; Minimal Residual Disease (MRD); Liquid Biopsy; Advanced Skin Cancer

Outcome Measures

Primary Outcomes (3)

• 2-year recurrence-free survival (RFS) in patients with detectable vs no detectable ctDNA after surgery

  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.

  24 Months

• Neoadjuvant Cohort Primary Outcome: Response Monitoring

  To evaluate ctDNA as a biomarker of response to neoadjuvant immunotherapy.

  24 Months

• Definitive Treatment Cohort Primary Outcome

  To evaluate whether ctDNA correlates with response to immunotherapy.

  24 Months

Secondary Outcomes (2)

• Post-Operative Cohort Secondary Outcome: Residual Free Survival (RFS) Surveillance over 2 Year

  24 Months

• Neoadjuvant Cohort Secondary Outcome: Correlation with Pathological Response

  24 Months

Other Outcomes (1)

• Exploratory Outcome

  24 Months

Study Arms (3)

Post-Operative Cohort

Cutaneous Squamous Cell Carcinoma cancer patients treated with surgery.

Diagnostic Test: Blood and Tissue Collection

Neoadjuvant Cohort

Cutaneous Squamous Cell Carcinoma patients treated with Neoadjuvant immunotherapy.

Diagnostic Test: Blood and Tissue Collection

Definitive Immunotherapy Cohort

Cutaneous Squamous Cell Carcinoma patients treated with definitive immunotherapy.

Diagnostic Test: Blood and Tissue Collection

Interventions

Blood and Tissue Collection DIAGNOSTIC_TEST

Blood samples, and tissue samples will be collected from the participants, and used to determine whether circulating tumor DNA (ctDNA) testing can help monitor treatment in patients with CSCC, and to determine how ctDNA levels change in patients.

Also known as: ctDNA test

Definitive Immunotherapy Cohort; Neoadjuvant Cohort; Post-Operative Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients ages 18 and older, who have been diagnosed with cutaneous squamous cell carcinoma (CSCC)

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
• 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.
• Definitive Immunotherapy Cohort
• Patients with unresectable locally advanced or metastatic CSCC, AJCC (8th ed) Stage II, III, or IV), receiving immunotherapy as part of standard of care.
• Patients undergoing systemic therapies outside the standard of care or enrolled in conflicting clinical trials.

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead
• Haystack Oncology, Inc.: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (1)

Massachusetts Eye and Ear

Boston, Massachusetts, 02114, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma and CSCC tumor tissue- Tumor biopsy specimens will be used to develop personalized ctDNA assay. Blood will be serially collected for ctDNA analysis. DNA is extracted from these tissues for assay development and assessment/analysis.

MeSH Terms

Conditions

Skin Neoplasms; Neoplasm, Residual

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Sophia Z. Shalhout, PhD

  Massachusetts Eye and Ear

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Cheung, MSc, CCRP

CONTACT

6175736060; mcheung0@meei.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: March 13, 2025
• Study Start: March 24, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)