Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
40 participants
OBSERVATIONAL
2023-04-26
2026-01-31
Brief Summary
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* Patients presenting with large, high-grade, localized LMS are at significant risk of developing metastasis following curative surgery.
* Clinical trials of neoadjuvant or adjuvant anthracycline and ifosfamide have suggested that patients with localized STS who are at high-risk of metastasis may benefit from chemotherapy, but the magnitude of benefit in unselected patient population is relatively small.
* Currently, patient age, and tumor size and grade are used to assess risk of metastases and survival
* Studies evaluating tumor response by imaging and histopathology have not established correlation between tumor characteristics as biomarkers for risk of metastasis or sarcoma recurrence.
* Circulating tumor DNA (ctDNA) is present in blood of patients with advanced/metastatic LMS and may serve as biomarker of tumor response to chemotherapy. Blood samples will be collected prior to, during and after 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. Patients will be followed for 2 years after study entry for signs of sarcoma recurrence.
* 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Blood and Tissue collection
Blood and tissue will be collected and analyzed for detection of ctDNA and genetic change
Eligibility Criteria
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Inclusion Criteria
* Grade 2 or 3, or high-grade LMS
* Tumor size \>5 cm in greatest dimension
* Primary tumor amenable to complete resection
* There is no age requirement
* Participant agrees to receive neoadjuvant doxorubicin and ifosfamide combination chemotherapy
* If pre-operative radiation is administered, it must be administered after chemotherapy. Post-operative radiation may be administered
* Archival tumor tissue (either frozen sample, tissue block containing tumor, or minimum of 4 unstained slides and 1 H\&E stained slide) from diagnostic or pre-treatment biopsy available for study research
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Michigan Rogel Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Scott Schuetze
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Rogal Cancer Center
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Scott Schuetze, MD/PhD
Role: primary
Brittany Siontis, MD
Role: primary
Elizabeth J Davis, MD
Role: primary
References
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Kasper B, Wilky BA. Sounding the Alarm on Leiomyosarcoma Recurrence: Role of Circulating Tumor DNA. Clin Cancer Res. 2022 Jun 13;28(12):2480-2481. doi: 10.1158/1078-0432.CCR-22-0738.
Other Identifiers
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HUM00213723
Identifier Type: OTHER
Identifier Source: secondary_id
HUM00219057
Identifier Type: -
Identifier Source: org_study_id
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