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NCT04925089 · ClinicalTrials.gov registry record
Localized Leiomyosarcoma Biomarker Protocol
A clinical trial of Leiomyosarcoma, sponsored by University of Michigan Rogel Cancer Center.
- Recruiting
- Registry status
- 40
- Enrollment target
- 3
- Study locations
NCT04925089: Recruiting study of Leiomyosarcoma, sponsored by University of Michigan Rogel Cancer Center.
NCT04925089 is a study of Leiomyosarcoma that is actively recruiting participants, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 40 participants, below the 119-participant average among 16 other Leiomyosarcoma trials with a reported enrollment target (66% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04925089, a study of Leiomyosarcoma, is actively recruiting participants, sponsored by University of Michigan Rogel Cancer Center.
- RECRUITING
- Registry status
- 40 participants
- Enrollment target
- 3
- Study locations
Study Summary
* Leiomyosarcoma (LMS) is one of the more common soft tissue sarcomas (STS). * Patients presenting with large, high-grade, localized LMS are at significant risk of developing metastasis following curative surgery. * Clinical trials of neoadjuvant or adjuvant anthracycline and ifosfamide have suggested that patients with localized STS who are at high-risk of metastasis may benefit from chemotherapy, but the magnitude of benefit in unselected patient population is relatively small. * Currently, patient age, and tumor size and grade are used to assess risk of metastases and survival * Studies evaluating tumor response by imaging and histopathology have not established correlation between tumor characteristics as biomarkers for risk of metastasis or sarcoma recurrence. * Circulating tumor DNA (ctDNA) is present in blood of patients with advanced/metastatic LMS and may serve as biomarker of tumor response to chemotherapy. Blood samples will be collected prior to, during and after chemotherapy and analyzed for ctDNA and for mutations in genes that are associated with increased risk of developing sarcoma. Tumor tissue will be collected and analyzed for changes in genes. Digital images of the sarcoma from CT or MRI scans obtained during treatment will be obtained for advanced radiomic analysis. Patients will be followed for 2 years after study entry for signs of sarcoma recurrence. * A biomarker of tumor response and patient survival benefit from chemotherapy early in the course of chemotherapy would be of significant impact in treatment planning.
Primary Outcome
Tumor characteristics from imaging will be compared to the presence of circulating tumor DNA , obtained from blood samples over multiple time points
Conditions Studied
Interventions
- OTHER Blood and Tissue collection
Study Locations (3)
Michigan
- University of Michigan - Ann Arbor
Minnesota
- Mayo Clinic - Rochester
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-04-26 |
| Est. Completion | 2026-06 |
What NCT04925089 shows while recruiting
NCT04925089 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 119-participant average among 16 other Leiomyosarcoma trials with a reported enrollment target (66% lower).
The record links to 1 condition, with Leiomyosarcoma appearing as the primary indexed condition, and to 1 intervention - of which Blood and Tissue collection is the first listed.
NCT04925089 reports a single indexed study location in Michigan, Minnesota, Tennessee.
Frequently Asked Questions
What is clinical trial NCT04925089 about?
NCT04925089 is a clinical study titled "Localized Leiomyosarcoma Biomarker Protocol". * Leiomyosarcoma (LMS) is one of the more common soft tissue sarcomas (STS). * Patients presenting with large, high-grade, localized LMS are at significant risk of developing metastasis following curative surgery. * Clinical trials of neoadjuvant or adjuvant anthracycline and ifosfamide have suggest...
What is the current status of trial NCT04925089?
This trial is currently recruiting. The enrollment target is 40 participants. The study started on 2023-04-26. Estimated completion is 2026-06.
What conditions does trial NCT04925089 study?
This clinical trial studies the following conditions: Leiomyosarcoma.
What interventions are being tested in trial NCT04925089?
The interventions under investigation include: Blood and Tissue collection (OTHER).
Who is sponsoring clinical trial NCT04925089?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04925089 being conducted?
This trial has 3 study locations across Michigan, Minnesota, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Leiomyosarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04925089's enrollment target sits among peer trials
40 9th of 16 higher than 7 of 16 other Leiomyosarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leiomyosarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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