Metastatic Leiomyosarcoma Biomarker Protocol
Recruiting now
Conditions studied: Leiomyosarcoma
In brief
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.
Key facts
- Study ID
- NCT05653388
- Run by
- University of Michigan Rogel Cancer Center
- People needed
- 200
- Starts
- 2022-12-22
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-06-24
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with unresectable or metastatic leiomyosarcoma (LMS). There is no age requirement
- Receiving first-line chemotherapy with doxorubicin- based or gemcitabine/docetaxel
- Target lesions per RECIST 1.1
- Optional archival tumor tissue including 1 H\&E-stained slide and unstained tumor tissue [either tissue block containing tumor, or minimum of 4 unstained slides (preferably 8 unstained slides)-fresh frozen sample may also be used in lieu of FFPE sample] available for study research
Where it is running
- Sarcoma Oncology Research Center — Santa Monica, California, United States (enrolling)
- University of Miami — Miami, Florida, United States (enrolling)
- Dana- Farber — Boston, Massachusetts, United States (enrolling)
- University of Michigan Cancer Center — Ann Arbor, Michigan, United States (enrolling)
- Mayo Clinic — Rochester, Minnesota, United States (enrolling)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
- Ohio State University — Columbus, Ohio, United States (enrolling)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
- MD Anderson — Houston, Texas, United States (enrolling)
- Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia (enrolling)
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (enrolling)
Full record on ClinicalTrials.gov
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