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.
Study Type
OBSERVATIONAL
Enrollment
200
Patients will provide tissue and blood samples. No medical intervention will be completed for study purposes
Sarcoma Oncology Research Center
Santa Monica, California, United States
RECRUITINGUniversity of Miami
Miami, Florida, United States
RECRUITINGDana- Farber
Boston, Massachusetts, United States
RECRUITINGUniversity of Michigan Cancer Center
Ann Arbor, Michigan, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGOhio State University
Columbus, Ohio, United States
RECRUITINGVanderbilt University Medical Center
Nashville, Tennessee, United States
RECRUITINGMD Anderson
Houston, Texas, United States
RECRUITINGChris O'Brien Lifehouse
Camperdown, New South Wales, Australia
RECRUITING...and 1 more locations
Change in ctDNA with RECIST
To examine the correlation of change in ctDNA with objective tumor response per RECIST. Analysis will occur at each subsequent early time-point (pre-cycle 1 and pre-cycle 2).
Time frame: 4 years from study start
Change in ctDNA with progression free survival (PFS)
To examine the correlation of change in ctDNA with progression free survival (PFS). Analysis of ctDNA will occur at each subsequent early time-point (pre-cycle 1 and pre-cycle 2). A Cox regression model will determine whether the baseline ctDNA levels are associated with PFS.
Time frame: 54 months from study start
Frequency of ctDNA in patients with unresectable or metastatic leiomyosarcoma.
Plasma collections for ctDNA analysis will be collected at each subsequent early time-point (pre-cycle 1 and pre-cycle 2).
Time frame: 4 years from study start
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