Biomarker analysis for metastatic leiomyosarcoma patients
Observational Study of Biomarkers of Disease-related Outcomes in Patients With Metastatic Leiomyosarcoma Receiving Chemotherapy
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | University of Michigan Rogel Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, doxorubicin |
| Locations | 11 sites (Santa Monica, California and 10 other locations) |
| Trial ID | NCT05653388 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with unresectable or metastatic leiomyosarcoma who are starting first-line chemotherapy with doxorubicin or gemcitabine/docetaxel.
Not a fit: Patients with resectable leiomyosarcoma or those not receiving the specified chemotherapy regimens may not benefit from this study.
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 performed: Other studies have shown promise in using ctDNA as a biomarker in various cancers, suggesting potential success for this approach in leiomyosarcoma.
Eligibility criteria
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 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 this trial is running
Santa Monica, California and 10 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.