Actively Recruiting
Localized Leiomyosarcoma Biomarker Protocol
Led by University of Michigan Rogel Cancer Center · Updated on 2026-02-17
40
Participants Needed
3
Research Sites
161 weeks
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 one of the more common soft tissue sarcomas (STS). * Patients presenting with large, high-grade, localized LMS are at significant risk of developing metastasis following curative surgery. * Clinical trials of neoadjuvant or adjuvant anthracycline and ifosfamide have suggested that patients with localized STS who are at high-risk of metastasis may benefit from chemotherapy, but the magnitude of benefit in unselected patient population is relatively small. * Currently, patient age, and tumor size and grade are used to assess risk of metastases and survival * Studies evaluating tumor response by imaging and histopathology have not established correlation between tumor characteristics as biomarkers for risk of metastasis or sarcoma recurrence. * Circulating tumor DNA (ctDNA) is present in blood of patients with advanced/metastatic LMS and may serve as biomarker of tumor response to chemotherapy. Blood samples will be collected prior to, during and after chemotherapy and analyzed for ctDNA and for mutations in genes that are associated with increased risk of developing sarcoma. Tumor tissue will be collected and analyzed for changes in genes. Digital images of the sarcoma from CT or MRI scans obtained during treatment will be obtained for advanced radiomic analysis. Patients will be followed for 2 years after study entry for signs of sarcoma recurrence. * A biomarker of tumor response and patient survival benefit from chemotherapy early in the course of chemotherapy would be of significant impact in treatment planning.
CONDITIONS
Official Title
Localized Leiomyosarcoma Biomarker Protocol
Who Can Participate
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 >5 cm in greatest dimension
- Primary tumor amenable to complete resection
- There is no age requirement
- Participant agrees to receive neoadjuvant doxorubicin and ifosfamide combination chemotherapy
- If pre-operative radiation is administered, it must be administered after chemotherapy. Post-operative radiation may be administered
- Archival tumor tissue (either frozen sample, tissue block containing tumor, or minimum of 4 unstained slides and 1 H&E stained slide) from diagnostic or pre-treatment biopsy available for study 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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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
Research Team
S
Scott Schuetze
CONTACT
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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