Actively Recruiting

All Genders
NCT05653388

Metastatic Leiomyosarcoma Biomarker Protocol

Led by University of Michigan Rogel Cancer Center · Updated on 2025-12-26

200

Participants Needed

11

Research Sites

205 weeks

Total Duration

On this page

Sponsors

U

University of Michigan Rogel Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Metastatic Leiomyosarcoma Biomarker Protocol

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with unresectable or metastatic leiomyosarcoma (LMS) with no age limit
  • Receiving first-line chemotherapy with doxorubicin or gemcitabine/docetaxel
  • Presence of target lesions measurable by RECIST 1.1
  • Optional archival tumor tissue available for research, including H&E-stained slides and unstained tumor tissue or fresh frozen samples
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 11 locations

1

Sarcoma Oncology Research Center

Santa Monica, California, United States, 90403

Actively Recruiting

2

University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

3

Dana- Farber

Boston, Massachusetts, United States, 02215

Actively Recruiting

4

University of Michigan Cancer Center

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

5

Mayo Clinic

Rochester, Minnesota, United States, 55901

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

7

Ohio State University

Columbus, Ohio, United States, 43210

Actively Recruiting

8

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

9

MD Anderson

Houston, Texas, United States, 77030

Actively Recruiting

10

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia, 2050

Actively Recruiting

11

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia, 3000

Actively Recruiting

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Research Team

S

Scott Schuetze

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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