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| ID | Type | Description | Link |
|---|---|---|---|
| 1P50CA272170-01 | U.S. NIH Grant/Contract | View source | |
| HUM00219342 | Other Identifier | University of Michigan | |
| HUM00216516 | Other Identifier | University of Michigan |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enrolled Subjects | Once enrolled subjects will provide Optional Archival Tissue, Optional Fresh tumor for a biopsy and blood collections at baseline, optional day 8 of cycle 1, day 1 of cycles 2-6 and at progression |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma Collection | Other | Patients will provide tissue and blood samples. No medical intervention will be completed for study purposes |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 54 months from study start |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 4 years from study start |
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Inclusion Criteria:
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Patients with unresectable or metastatic leiomyosarcoma
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Scott Schuetze | Contact | 734-647-8921 | scotschu@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Scott Schuetze | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarcoma Oncology Research Center | Recruiting | Santa Monica | California | 90403 | United States |
We will share deidentified genetic data on the NIH site, and deidentified imaging data will be shared with the lab at Columbia University. We are not sharing patient identities.
At the end of the study
We will share deidentified genetic data on the NIH site, and deidentified imaging data will be shared with the lab at Columbia University. We are not sharing patient identities.
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| ID | Term |
|---|---|
| D007890 | Leiomyosarcoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Optional Archival Tissue, Optional Fresh tumor biopsy, blood collections prior to day 1 of first chemotherapy, optional day 8 of cycle 1, day 1 of cycles 2-6 and at progression of sarcoma
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| Dana- Farber | Recruiting | Boston | Massachusetts | 02215 | United States |
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| University of Michigan Cancer Center | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Mayo Clinic | Recruiting | Rochester | Minnesota | 55901 | United States |
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| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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| Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
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| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| MD Anderson | Recruiting | Houston | Texas | 77030 | United States |
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| Chris O'Brien Lifehouse | Recruiting | Camperdown | New South Wales | 2050 | Australia |
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| Peter MacCallum Cancer Centre | Recruiting | Melbourne | Victoria | 3000 | Australia |
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| D012509 | Sarcoma |