Observational Study of Biomarkers of Disease-related Outcomes in Patients With Metastatic Leiomyosarcoma Receiving Chemotherapy
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.
Arms & interventions
- OtherPlasma Collection
Patients will provide tissue and blood samples. No medical intervention will be completed for study purposes
Outcome measures
Primary
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
Secondary
Frequency of ctDNA in patients with unresectable or metastatic leiomyosarcoma.
Time frame: 4 years from study start
Eligibility criteria
Study locations (9)
Sarcoma Oncology Research Center
Santa Monica, California, 90403
University of Miami
Miami, Florida, 33136
Dana- Farber
Boston, Massachusetts, 02215
University of Michigan Cancer Center
Ann Arbor, Michigan, 48109
Mayo Clinic
Rochester, Minnesota, 55901
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Ohio State University
Columbus, Ohio, 43210
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
MD Anderson
Houston, Texas, 77030