Biomarker study for localized leiomyosarcoma
Official title: Pilot Study of ctDNA and Imaging Characteristics as Biomarkers of Disease-related Outcomes in Patients With Localized Leiomyosarcoma Receiving Chemotherapy
Run by University of Michigan Rogel Cancer Center · NCT04925089 · Data updated 2026-11-12
This study is testing if a blood test for tumor DNA can help predict how well chemotherapy works for people with localized leiomyosarcoma who are at high risk of their cancer spreading after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University of Michigan Rogel Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation, doxorubicin |
| Locations | 3 sites (Ann Arbor, Michigan and 2 other locations) |
| Status | Recruiting |
| Started | April 26, 2023 |
| Main results expected | November 2026 |
| Study ends | November 2026 |
| Registry record updated | July 2, 2026 |
| Trial ID | NCT04925089 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with high-grade localized leiomyosarcoma of the extremity, body wall, or retroperitoneum, with tumors larger than 5 cm.
✕Probably not a fit
Patients with low-grade tumors or those whose tumors are not amenable to complete resection 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 localized leiomyosarcoma (LMS) who are at high risk of metastasis following surgery. It aims to evaluate circulating tumor DNA (ctDNA) as a potential biomarker for tumor response to chemotherapy. Blood samples will be collected from participants before, during, and after receiving neoadjuvant chemotherapy with doxorubicin and ifosfamide. The study will also analyze archival tumor tissue to correlate with ctDNA findings and assess the risk of metastasis and recurrence.
Why it matters
Potential benefit: If successful, this study could improve the ability to predict metastasis and tailor chemotherapy for patients with localized leiomyosarcoma.
How similar studies have gone: Other studies have explored the use of ctDNA in various cancers, showing promising results, but this specific approach in localized LMS is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with localized leiomyosarcoma (LMS) of extremity, body wall or retroperitoneum * 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
Where it's running
-
University of Michigan
Ann Arbor, Michigan, United States Recruiting -
Mayo Clinic
Rochester, Minnesota, United States Recruiting -
Vanderbilt University Medical Center
Nashville, Tennessee, United States Recruiting
Study contacts
- Principal investigator: Scott Schuetze — University of Michigan Rogal Cancer Center
- Study coordinator: Scott Schuetze
- Email: scotschu@med.umich.edu
- Phone: 7346478921
Similar studies
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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.