Using blood tests to monitor skin cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the use of circulating tumor DNA (ctDNA) as a non-invasive biomarker for detecting residual disease and monitoring treatment responses in patients with cutaneous squamous cell carcinoma (CSCC). Blood samples will be collected during regular treatment visits or through mobile phlebotomy, allowing researchers to analyze changes in ctDNA levels over time. The study aims to evaluate the potential of ctDNA to provide insights into tumor dynamics during and after surgery or immunotherapy. Participants will be monitored for a duration of two years to assess the effectiveness of this approach.

Why it matters

Who can join: the full rules

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.

Where it's running

• Massachusetts Eye and Ear
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Sophia Z. Shalhout, PhD — Massachusetts Eye and Ear
• Study coordinator: Michael Cheung, MSc, CCRP
• Email: mcheung0@meei.harvard.edu
• Phone: 6175736060

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using immunotherapy to treat cutaneous squamous cell carcinoma without surgery

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.