RecruitingNCT05653388

Metastatic Leiomyosarcoma Biomarker Protocol

Observational Study of Biomarkers of Disease-related Outcomes in Patients With Metastatic Leiomyosarcoma Receiving Chemotherapy


Sponsor

University of Michigan Rogel Cancer Center

Enrollment

200 participants

Start Date

Dec 22, 2022

Study Type

OBSERVATIONAL

Conditions

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

Inclusion Criteria4

  • Patients with unresectable or metastatic leiomyosarcoma (LMS). There is no age requirement
  • Receiving first-line chemotherapy with doxorubicin 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

OTHERPlasma Collection

Patients will provide tissue and blood samples. No medical intervention will be completed for study purposes


Locations(11)

Sarcoma Oncology Research Center

Santa Monica, California, United States

University of Miami

Miami, Florida, United States

Dana- Farber

Boston, Massachusetts, United States

University of Michigan Cancer Center

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Ohio State University

Columbus, Ohio, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

MD Anderson

Houston, Texas, United States

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

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NCT05653388


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