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NCT05653388 · ClinicalTrials.gov registry record
Metastatic Leiomyosarcoma Biomarker Protocol
A clinical trial of Leiomyosarcoma, sponsored by University of Michigan Rogel Cancer Center.
- Recruiting
- Registry status
- 200
- Enrollment target
- 11
- Study locations
NCT05653388 is a study of Leiomyosarcoma that is actively recruiting participants, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 200 participants, above the 109-participant average among 16 other Leiomyosarcoma trials with a reported enrollment target (83% higher). The trial reports 11 study locations across 11 states.
The verdict
NCT05653388, a study of Leiomyosarcoma, is actively recruiting participants, sponsored by University of Michigan Rogel Cancer Center.
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 11
- Study locations
Study Summary
Leiomyosarcoma (LMS) is one of the most prevalent soft tissue sarcomas (STS) and can occur in various sites including soft tissue, uterus and retroperitoneal large vessels. Metastatic disease occurs in approximately 50% of patients diagnosed with leiomyosarcoma and prognosis is poor in setting of metastatic disease. A minority of patients benefit from treatment with chemotherapy and early biomarkers of benefit from treatment are lacking. 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. Circulating tumor DNA (ctDNA) is present in blood of patients with advanced/metastatic cancer and may serve as biomarker of tumor response to chemotherapy. Blood samples will be collected prior to and during and 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. Study participants will be asked to complete a questionnaire on attitudes and understanding of genetics and genetic testing.
Conditions Studied
Interventions
- OTHER Plasma Collection
Study Locations (11)
California
- Sarcoma Oncology Research Center - Santa Monica
Florida
- University of Miami - Miami
Massachusetts
- Dana- Farber - Boston
Michigan
- University of Michigan Cancer Center - Ann Arbor
Minnesota
- Mayo Clinic - Rochester
New York
- Memorial Sloan Kettering Cancer Center - New York
Ohio
- Ohio State University - Columbus
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2022-12-22 |
| Est. Completion | 2026-12 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05653388
The ClinicalTrials.gov registry entry for NCT05653388 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 109-participant average among 16 other Leiomyosarcoma trials with a reported enrollment target (83% higher). The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Leiomyosarcoma appearing as the primary indexed condition, and to 1 intervention - of which Plasma Collection is the first listed.
NCT05653388 reports 11 study locations spanning 11 distinct geographic areas - top geographies include California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05653388 about?
NCT05653388 is a clinical study titled "Metastatic Leiomyosarcoma Biomarker Protocol". Leiomyosarcoma (LMS) is one of the most prevalent soft tissue sarcomas (STS) and can occur in various sites including soft tissue, uterus and retroperitoneal large vessels. Metastatic disease occurs in approximately 50% of patients diagnosed with leiomyosarcoma and prognosis is poor in setting of me...
What is the current status of trial NCT05653388?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2022-12-22. Estimated completion is 2026-12.
What conditions does trial NCT05653388 study?
This clinical trial studies the following conditions: Leiomyosarcoma.
What interventions are being tested in trial NCT05653388?
The interventions under investigation include: Plasma Collection (OTHER).
Who is sponsoring clinical trial NCT05653388?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05653388 being conducted?
This trial has 11 study locations across California, Florida, Massachusetts, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.