Metastatic Leiomyosarcoma Biomarker Protocol (NCT05653388)
Observational Study of Biomarkers of Disease-related Outcomes in Patients With Metastatic Leiomyosarcoma Receiving Chemotherapy
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Sarcoma Oncology Research Center — Santa Monica, California
🧪 Interventions in This Study
- Plasma Collection (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (11 Sites)
- Sarcoma Oncology Research Center — Santa Monica, California
- University of Miami — Miami, Florida
- Dana- Farber — Boston, Massachusetts
- University of Michigan Cancer Center — Ann Arbor, Michigan
- Mayo Clinic — Rochester, Minnesota
- Memorial Sloan Kettering Cancer Center — New York, New York
- Ohio State University — Columbus, Ohio
- Vanderbilt University Medical Center — Nashville, Tennessee
- MD Anderson — Houston, Texas
- Chris O'Brien Lifehouse — Camperdown, New South Wales
- Peter MacCallum Cancer Centre — Melbourne, Victoria
📞 Contact the Study Coordinator
Phone: (734) 647-8921
Email: scotschu@med.umich.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Leiomyosarcoma
- A Study of Rucaparib and Nivolumab in People With Leiomyosarcoma — Basking Ridge, New Jersey
- Nivolumab and BO-112 Before Surgery for the Treatment of Resectable Soft Tissue Sarcoma — Los Angeles, California
- Talimogene Laherparepvec and Radiation Therapy in Treating Patients With Newly Diagnosed Soft Tissue Sarcoma That Can Be Removed by Surgery — Phoenix, Arizona
- Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo) — Phoenix, Arizona
- A Phase I Trial of Combination Gemcitabine and Nab-Sirolimus in Advanced Leiomyosarcomas or Advanced Soft-Tissue Sarcomas With TSC2 or TSC1 Loss-of-function Mutations or Deletions — Houston, Texas
- Metronomic Trabectedin, Gemcitabine, and Dacarbazine for Soft Tissue Sarcoma — Santa Monica, California
Explore by condition: All Leiomyosarcoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.