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Observational Study for Metastatic Leiomyosarcoma

This study is looking at how a marker in your blood, called circulating tumor DNA (ctDNA), changes when you're being treated for metastatic leiomyosarcoma (a type of soft tissue cancer that has spread). Researchers want to see if ctDNA can help predict how well treatments like doxorubicin-based chemotherapy or gemcitabine/docetaxel chemotherapy are working. You can join if you have unresectable (cannot be surgically removed) or metastatic leiomyosarcoma and are starting one of these first-line chemotherapy treatments. The study aims to understand if changes in ctDNA can show early on if a treatment is effective and how long patients live without their cancer getting worse. This is an observational study, meaning you will provide samples, but no new medical interventions are given for the study itself.

Study design
This is an observational study planning to enroll 200 participants. It is not specified if it is randomized or blinded.
What's involved
You would provide tissue and blood samples. No medical intervention will be completed for study purposes.
Compensation
Not stated in the trial record.
Follow-up
Your ctDNA changes will be measured at 4 years from the study start, and progression-free survival will be measured at 54 months from the study start.

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NCT05653388

Metastatic Leiomyosarcoma Biomarker Protocol

Recruiting
Not specifiedAll AgesObservational
University of Michigan Rogel Cancer Center
~200 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:Plasma Collection

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in ctDNA with RECIST
Measured over 4 years from study start
+1 more outcome measured

Conditions

Leiomyosarcoma

Explore related trials

LeiomyosarcomaCirculating Tumor-Derived DNA Negative

Where it's being run

11 sites across 11 states
California1
Florida1
Massachusetts1
Michigan1
Minnesota1
New York1
Ohio1
Tennessee1

Study leadership

  • Scott Schuetze · PRINCIPAL_INVESTIGATOR · University of Michigan Rogel Cancer Center

Who to contact

Scott Schuetze
[email protected]
734-647-8921
Email the study team

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Eligibility criteria

Inclusion

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

What this trial measures

  • Change in ctDNA with RECIST4 years from study start

    To examine the correlation of change in ctDNA with objective tumor response per RECIST. Analysis will occur at each subsequent early time-point (pre-cycle 1 and pre-cycle 2).

  • Change in ctDNA with progression free survival (PFS)54 months from study start

    To examine the correlation of change in ctDNA with progression free survival (PFS). Analysis of ctDNA will occur at each subsequent early time-point (pre-cycle 1 and pre-cycle 2). A Cox regression model will determine whether the baseline ctDNA levels are associated with PFS.