Blood Markers in Patients With Metastatic Leiomyosarcoma Receiving Chemotherapy
Studies blood samples from people with spreading leiomyosarcoma who are receiving chemotherapy.
Plain-language title generated from the registry record
Registry title: Metastatic Leiomyosarcoma Biomarker Protocol
Key facts
- Where
- Ann Arbor, Boston, Columbus, Houston, Miami, Nashville, New York, Rochester, and Santa Monica, United StatesSee the 9 sites
Where in United States
- University of Michigan Cancer CenterAnn Arbor, United StatesTaking people
- Dana FarberBoston, United StatesTaking people
- Ohio State UniversityColumbus, United StatesTaking people
- MD AndersonHouston, United StatesTaking people
- University of MiamiMiami, United StatesTaking people
- Vanderbilt University Medical CenterNashville, United StatesTaking people
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
- Mayo ClinicRochester, United StatesTaking people
- Sarcoma Oncology Research CenterSanta Monica, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Michigan Rogel Cancer Center
- Trial code
- NCT05653388
- Record updated
- 24 June 2026
- Original description
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.Read full original descriptionShow less
Observational Study of Biomarkers of Disease-related Outcomes in Patients With Metastatic Leiomyosarcoma Receiving Chemotherapy
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.
Inclusion: 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.