Actively Recruiting
Metastatic Leiomyosarcoma Biomarker Protocol
Led by University of Michigan Rogel Cancer Center · Updated on 2025-12-26
200
Participants Needed
11
Research Sites
205 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 most prevalent soft tissue sarcomas (STS) and can occur in various sites including soft tissue, uterus and retroperitoneal large vessels. Metastatic disease occurs in approximately 50% of patients diagnosed with leiomyosarcoma and prognosis is poor in setting of metastatic disease. A minority of patients benefit from treatment with chemotherapy and early biomarkers of benefit from treatment are lacking. 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. Circulating tumor DNA (ctDNA) is present in blood of patients with advanced/metastatic cancer and may serve as biomarker of tumor response to chemotherapy. Blood samples will be collected prior to and during and 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. Study participants will be asked to complete a questionnaire on attitudes and understanding of genetics and genetic testing.
CONDITIONS
Official Title
Metastatic Leiomyosarcoma Biomarker Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with unresectable or metastatic leiomyosarcoma (LMS) with no age limit
- Receiving first-line chemotherapy with doxorubicin or gemcitabine/docetaxel
- Presence of target lesions measurable by RECIST 1.1
- Optional archival tumor tissue available for research, including H&E-stained slides and unstained tumor tissue or fresh frozen samples
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Sarcoma Oncology Research Center
Santa Monica, California, United States, 90403
Actively Recruiting
2
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
3
Dana- Farber
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
5
Mayo Clinic
Rochester, Minnesota, United States, 55901
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
8
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
9
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
10
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
11
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
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
1
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