Observational Study for Localized Leiomyosarcoma

This study is looking at people with localized leiomyosarcoma (a type of soft tissue cancer) that is high-grade and larger than 5 cm. We want to understand if changes in circulating tumor DNA (ctDNA), which are tiny pieces of cancer DNA in your blood, are linked to how your tumor looks on an MRI scan. We're also studying how ctDNA levels change in patients receiving chemotherapy with doxorubicin and ifosfamide, sometimes with radiation, before surgery. This study is for patients whose tumor can be completely removed and who agree to receive this specific chemotherapy. We hope to find better ways to predict how leiomyosarcoma will behave. The current status of this study is unclear.

Study design
This is an observational study, meaning researchers will collect information without giving new treatments. It plans to enroll 40 participants.
What's involved
Blood and tissue samples will be collected and analyzed. Participants will receive neoadjuvant doxorubicin and ifosfamide combination chemotherapy.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 2 years to evaluate the study's main goals.

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NCT04925089

Localized Leiomyosarcoma Biomarker Protocol

Recruiting
Not specifiedAll AgesObservational
University of Michigan Rogel Cancer Center
~40 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Blood and Tissue collection

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the association between tumor characteristics assessed by contrast-enhanced MRI and location with presence of circulating tumor DNA (ctDNA) in patients with localized, high-grade leiomyosarcoma
Measured over 2 years
+1 more outcome measured
Leiomyosarcoma
3 sites across 3 states
Michigan1
Minnesota1
Tennessee1
  • Scott Schuetze · PRINCIPAL_INVESTIGATOR · University of Michigan Rogal Cancer Center

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Eligibility criteria

Inclusion

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
  • To evaluate the association between tumor characteristics assessed by contrast-enhanced MRI and location with presence of circulating tumor DNA (ctDNA) in patients with localized, high-grade leiomyosarcoma2 years

    Tumor characteristics from imaging will be compared to the presence of circulating tumor DNA , obtained from blood samples over multiple time points

  • To evaluate change in ctDNA in patients with localized, high-grade leiomyosarcoma undergoing preoperative doxorubicin/ifosfamide chemotherapy with or without pre-operative radiation2 years

    Blood will be collected at multiple timepoints. The presence of ctDNA will be assessed prior to, during, and after treatment with chemotherapy and / or radiation