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Observational Study of ctDNA in Cutaneous Squamous Cell Carcinoma

This study is looking at how a special blood test, called circulating tumor DNA (ctDNA), can help doctors monitor treatment and detect if cutaneous squamous cell carcinoma (CSCC), a type of skin cancer, comes back. Researchers will collect blood and tissue samples from people with CSCC who are having surgery or other standard treatments like immunotherapy. They want to see if changes in ctDNA levels in your blood can show how well treatment is working or if the cancer is returning. You might be able to join if you have surgically treatable CSCC with certain features, such as nerve involvement or high-risk characteristics like a large tumor size. The main goals are to see how many people remain cancer-free for two years based on their ctDNA levels after surgery, and to monitor treatment response in other groups. This is an observational study, meaning all treatments you receive are standard care, and the ctDNA test is for research purposes only.

Study design
This is an observational study planning to enroll 60 participants. It is not specified if it is randomized or blinded.
What's involved
You would provide blood and tissue samples during your regular treatment visits or through mobile visits. You would be in the study for 2 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months to assess recurrence-free survival and treatment response.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06875609

ctDNA in Cutaneous Squamous Cell Carcinoma

Recruiting
Not specifiedAges 18+Observational
Massachusetts Eye and Ear Infirmary
~60 participants
Updated 2026-03-30 on ClinicalTrials.gov
What's tested:Blood and Tissue Collection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
2-year recurrence-free survival (RFS) in patients with detectable vs no detectable ctDNA after surgery
Measured over 24 Months
+2 more outcomes measured

Conditions

Cutaneous Squamous Cell Carcinoma

Explore related trials

Skin Squamous Cell Carcinoma

NCT06875609

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Massachusetts Eye and Ear

    Boston, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sophia Z. Shalhout, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts Eye and Ear

Who to contact

Michael Cheung, MSc, CCRP
[email protected]
6175736060
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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
Patients with resectable AJCC (8th ed) Stage II, III or IV(M0) CSCC treated with neoadjuvant immunotherapy as part of standard care.
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

Patients with Cutaneous Squamous Cell Carcinoma not amenable to surgical resection
Patients receiving or undergoing systemic therapies.
Patients ineligible for neoadjuvant treatment.
Patients undergoing systemic therapies outside the standard of care or enrolled in conflicting clinical trials.

What this trial measures

  • 2-year recurrence-free survival (RFS) in patients with detectable vs no detectable ctDNA after surgery24 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 Monitoring24 Months

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

  • Definitive Treatment Cohort Primary Outcome24 Months

    To evaluate whether ctDNA correlates with response to immunotherapy.