Sounding the Alarm on Leiomyosarcoma Recurrence: Role of Circulating Tumor DNA.
Bernd Kasper, Breelyn A Wilky
https://pubmed.ncbi.nlm.nih.gov/35412607Actively Recruiting
All Genders
ID04925089
Pilot Study of ctDNA and Imaging as Biomarkers in Patients With Localized High-Grade Leiomyosarcoma Receiving Chemotherapy
Led by University of Michigan Rogel Cancer Center · Updated on 2026-02-17
40
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Michigan Rogel Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Leiomyosarcoma (LMS) is a common type of soft tissue sarcoma, and patients with large, high-grade, localized LMS have a high risk of metastasis after surgery. This trial aims to study biomarkers, such as circulating tumor DNA (ctDNA) and imaging features, to better predict tumor response to chemotherapy and patient outcomes. Current risk assessments use age, tumor size, and grade, but new biomarkers may improve treatment planning for LMS patients. Participants in this observational study will have blood and tumor tissue collected to analyze ctDNA and genetic changes. Imaging from CT or MRI scans will be used for advanced analysis. Patients will receive neoadjuvant chemotherapy with doxorubicin and ifosfamide, possibly followed by radiation therapy. The study will monitor changes in ctDNA and imaging features during and after treatment. During the study, participants will be followed for two years to monitor sarcoma recurrence and relapse-free survival. Blood samples and tumor tissue will be collected before, during, and after chemotherapy. Researchers will evaluate the relationship between tumor imaging, ctDNA presence and changes, and patient outcomes. This long-term follow-up aims to identify biomarkers that could guide treatment decisions and improve survival predictions.
CONDITIONS
Brief Title
Localized Leiomyosarcoma Biomarker Protocol
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with localized leiomyosarcoma (LMS) of extremity, body wall, or retroperitoneum
- Grade 2 or 3, or high-grade LMS
- Tumor size greater than 5 cm in greatest dimension
- Primary tumor amenable to complete resection
- No age requirement
- Participant agrees to receive neoadjuvant doxorubicin and ifosfamide chemotherapy
- If pre-operative radiation is given, it must be after chemotherapy; post-operative radiation may be given
- Archival tumor tissue from diagnostic or pre-treatment biopsy available for research
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 2 years
Participants have blood and tissue collected to analyze circulating tumor DNA (ctDNA) and genetic changes. Imaging assessments are performed to evaluate tumor characteristics.
Multiple visits for blood and tissue collection and imaging over 2 years
Trial Site Locations
Total: 3 locations
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
2
Mayo Clinic
Rochester, Minnesota, United States, 55901
Actively Recruiting
3
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
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Research Team
S
Scott Schuetze
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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