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Clinical trialNCT05653388RecruitingObservational

Metastatic Leiomyosarcoma Biomarker Protocol

SponsorUniversity of Michigan Rogel Cancer CenterEnrollment200Leiomyosarcoma
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

11 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia
  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, Australia

    Recruiting
  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, Australia

    Recruiting
United States
  • Sarcoma Oncology Research Center

    Santa Monica, California, United States

    Sant P Chawla, MD
    Recruiting
  • University of Miami

    Miami, Florida, United States

    Gina D'Amato, MD
    Recruiting
  • Dana- Farber

    Boston, Massachusetts, United States

    Recruiting
  • University of Michigan Cancer Center

    Ann Arbor, Michigan, United States

    Scott Schuetze, M.D., PhD
    Recruiting
  • Mayo Clinic

    Rochester, Minnesota, United States

    Recruiting
  • Memorial Sloan Kettering Cancer Center

    New York, New York, United States

    Recruiting
  • Ohio State University

    Columbus, Ohio, United States

    Recruiting
  • Vanderbilt University Medical Center

    Nashville, Tennessee, United States

    Recruiting
  • Md Anderson

    Houston, Texas, United States

    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
22 Dec 2022
Primary completion
31 Dec 2026
Completion
31 Dec 2026
Last update posted
24 Jun 2026
Registered enrollment
200
Registry id
NCT05653388

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.