Using blood tests to monitor skin cancer treatment
ctDNA Clearance and ctDNA Monitoring Study in Cutaneous Squamous Cell Carcinoma
This study is testing whether blood tests can help track how well treatment is working for people with skin cancer called cutaneous squamous cell carcinoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts Eye and Ear Infirmary Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06875609 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with surgically resectable primary CSCC with high-risk features or those receiving neoadjuvant immunotherapy.
Not a fit: Patients with CSCC that is not amenable to surgical resection or those undergoing systemic therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new method for early detection of cancer recurrence and better monitoring of treatment responses in patients with CSCC.
How similar studies have performed: Other studies have shown promise in using ctDNA as a biomarker for various cancers, indicating potential success for this approach in CSCC.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.