Recruiting

Liquid Biopsy

Sponsor:

Massachusetts Eye and Ear Infirmary

Code:

NCT06875609

Conditions

Cutaneous Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blood and Tissue Collection

Study Details

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

Study ID

NCT06875609

Start date

Mar 24, 2025

Status verified date

Mar, 2026

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Post-Operative Cohort

Cutaneous Squamous Cell Carcinoma cancer patients treated with surgery.

Neoadjuvant Cohort

Cutaneous Squamous Cell Carcinoma patients treated with Neoadjuvant immunotherapy.

Definitive Immunotherapy Cohort

Cutaneous Squamous Cell Carcinoma patients treated with definitive immunotherapy.

Interventions

Blood and Tissue Collection

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.

Primary outcome measure

  • 2-year recurrence-free survival (RFS) in patients with detectable vs no detectable ctDNA after surgery [ Time Frame: 24 Months ]
  • Neoadjuvant Cohort Primary Outcome: Response Monitoring [ Time Frame: 24 Months ]
  • Definitive Treatment Cohort Primary Outcome [ Time Frame: 24 Months ]

Central Contacts and Locations

Central contacts

Michael Cheung, MSc, CCRP

6175736060mcheung0@meei.harvard.edu

Locations

Massachusetts Eye and Ear

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Michael Cheung, MSc, CCRP

617-573-6060mcheung0@meei.harvard.edu

Principal Investigator:

Sophia Shalhout, PhD

More Information

Sponsor

Massachusetts Eye and Ear Infirmary

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts Eye and Ear Infirmary on 2026-03-30.