Back to Trials
NCT05653388Recruiting

Metastatic Leiomyosarcoma Biomarker Protocol

University of Michigan Rogel Cancer Center

Start Date

12/22/2022

Completion Date

12/1/2026

Summary

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.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: * 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

Interventions

OTHER

Plasma Collection

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Leiomyosarcoma

Locations

Sarcoma Oncology Research Center

Santa Monica, California 90403

United States

University of Miami

Miami, Florida 33136

United States

Dana- Farber

Boston, Massachusetts 02215

United States

University of Michigan Cancer Center

Ann Arbor, Michigan 48109

United States

Mayo Clinic

Rochester, Minnesota 55901

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Ohio State University

Columbus, Ohio 43210

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

MD Anderson

Houston, Texas 77030

United States

Chris O'Brien Lifehouse

Camperdown, New South Wales 2050

Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria 3000

Australia