Metastatic Leiomyosarcoma Biomarker Protocol
- Conditions
- Leiomyosarcoma
- Interventions
- Other: Plasma Collection
- Registration Number
- NCT05653388
- Lead Sponsor
- University of Michigan Rogel Cancer Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Enrolled Subjects Plasma Collection Once enrolled subjects will provide Archival Tissue, Optional Fresh tumor from a biopsy and blood collections at baseline, day 8 of cycle 1, day 1 of cycles 2-6, and at progression.
- Primary Outcome Measures
Name Time Method Change in ctDNA with RECIST 4 years from study start 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).
Change in ctDNA with progression free survival (PFS) 54 months from study start 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.
- Secondary Outcome Measures
Name Time Method Frequency of ctDNA in patients with unresectable or metastatic leiomyosarcoma. 4 years from study start Plasma collections for ctDNA analysis will be collected at each subsequent early time-point (pre-cycle 1 and pre-cycle 2).
Trial Locations
- Locations (9)
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