NCT06875609 ctDNA in Cutaneous Squamous Cell Carcinoma
| NCT ID | NCT06875609 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts Eye and Ear Infirmary |
| Condition | Cutaneous Squamous Cell Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-03-24 |
| Primary Completion | 2028-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2025-03-24 with a primary completion date of 2028-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Sophia Z. Shalhout, PhD
PRINCIPAL INVESTIGATOR
Massachusetts Eye and Ear
Frequently Asked Questions
Who can join the NCT06875609 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cutaneous Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06875609 currently recruiting?
Yes, NCT06875609 is actively recruiting participants. Contact the research team at mcheung0@meei.harvard.edu for enrollment information.
Where is the NCT06875609 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06875609 clinical trial?
NCT06875609 is sponsored by Massachusetts Eye and Ear Infirmary. The principal investigator is Sophia Z. Shalhout, PhD at Massachusetts Eye and Ear. The trial plans to enroll 60 participants.