Biomarker analysis for metastatic leiomyosarcoma patients
Official title: Observational Study of Biomarkers of Disease-related Outcomes in Patients With Metastatic Leiomyosarcoma Receiving Chemotherapy
Run by University of Michigan Rogel Cancer Center · NCT05653388 · Data updated 2026-11-12
This study is trying to see if blood and tissue samples can help find markers that show how well chemotherapy is working for patients with advanced leiomyosarcoma.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University of Michigan Rogel Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, doxorubicin |
| Locations | 11 sites (Santa Monica, California and 10 other locations) |
| Status | Recruiting |
| Started | December 22, 2022 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | June 24, 2026 |
| Trial ID | NCT05653388 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with unresectable or metastatic leiomyosarcoma who are starting first-line chemotherapy with doxorubicin or gemcitabine/docetaxel.
✕Probably not a fit
Patients with resectable leiomyosarcoma or those not receiving the specified chemotherapy regimens may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on patients with unresectable or metastatic leiomyosarcoma who are receiving first-line chemotherapy. It aims to collect and analyze blood samples for circulating tumor DNA (ctDNA) to identify potential biomarkers that could indicate tumor response and patient survival benefits from chemotherapy. Additionally, tumor tissue samples will be collected to investigate genetic mutations associated with sarcoma. The goal is to enhance treatment planning by identifying early indicators of treatment efficacy.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with metastatic leiomyosarcoma by identifying effective biomarkers.
How similar studies have gone: Other studies have shown promise in using ctDNA as a biomarker in various cancers, suggesting potential success for this approach in leiomyosarcoma.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with unresectable or metastatic leiomyosarcoma (LMS). There is no age requirement * Receiving first-line chemotherapy with doxorubicin- based 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
Where it's running
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Sarcoma Oncology Research Center
Santa Monica, California, United States Recruiting -
University of Miami
Miami, Florida, United States Recruiting -
Dana- Farber
Boston, Massachusetts, United States Recruiting -
University of Michigan Cancer Center
Ann Arbor, Michigan, United States Recruiting -
Mayo Clinic
Rochester, Minnesota, United States Recruiting -
Memorial Sloan Kettering Cancer Center
New York, New York, United States Recruiting
Show 5 more locations
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Ohio State University
Columbus, Ohio, United States Recruiting -
Vanderbilt University Medical Center
Nashville, Tennessee, United States Recruiting -
MD Anderson
Houston, Texas, United States Recruiting -
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia Recruiting -
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia Recruiting
Study contacts
- Principal investigator: Scott Schuetze — University of Michigan Rogel Cancer Center
- Study coordinator: Scott Schuetze
- Email: scotschu@med.umich.edu
- Phone: 734-647-8921
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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REC-617 treatment in RB1-negative leiomyosarcoma for adults who have had prior therapy
This study tests REC-617 to see if it can help control RB1-negative leiomyosarcoma in adults who have already received prior systemic treatment.
-
Methionine-Reduced Diet in Solid Tumors (early-phase)
A small pilot study will test whether a methionine-reduced diet can change blood levels in adults with various solid tumors who are receiving standard cancer therapy.
-
Ivonescimab treatment for people with leiomyosarcoma
We will try ivonescimab in adults with advanced or unresectable leiomyosarcoma to see if it controls the cancer and causes few or mild side effects.
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This trial tests whether selecting proton rather than standard X‑ray radiotherapy before surgery for adults with localized soft tissue sarcoma can lower long-term radiation side effects without increasing surgical complications.
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Combining STC-15 with Toripalimab for Advanced Cancers
This study is testing whether combining a new cancer drug, STC-15, with toripalimab can help people with advanced cancers feel better and improve their treatment outcomes.
-
Exploring beliefs and attitudes about genetic testing in leiomyosarcoma patients
This study looks at what leiomyosarcoma patients and their families think about genetic testing and how it might affect their understanding of cancer risk.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.