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RECRUITINGOBSERVATIONAL

Metastatic Leiomyosarcoma Biomarker Protocol

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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

Treatments Being Tested

OTHER

Plasma 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