Metastatic Leiomyosarcoma Biomarker Protocol
Purpose
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.
Condition
- Leiomyosarcoma
Eligibility
- Eligible Ages
- All ages
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Criteria
Inclusion Criteria:
- Patients with unresectable or metastatic leiomyosarcoma (LMS). There is no age
requirement
- Receiving first-line chemotherapy with doxorubicin or gemcitabine/docetaxel
- Sum of target lesions per RECIST1.1 of 5 cm or greater
- Archival tumor tissue including 1 H&E stained slide and unstained tumor tissue
(either tissue block containing tumor, or minimum of 4 unstained slides - fresh
frozen sample may also be used in lieu of FFPE sample) available for study research
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Enrolled Subjects | 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. |
|
Recruiting Locations
Nashville, Tennessee 37232
Elizabeth J Davis, MD
615-322-5000
More Details
- Status
- Recruiting
- Sponsor
- University of Michigan Rogel Cancer Center