Metastatic Leiomyosarcoma Biomarker Protocol

Recruiting

• Conditions: Leiomyosarcoma

• Registration Number: NCT05653388
• Lead Sponsor: University of Michigan Rogel Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2022-12-07
• Study First Posted: 2022-12-16
• Study Start: 2022-12-22
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-02
• Primary Completion: 2026-12
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients with unresectable or metastatic leiomyosarcoma (LMS). There is no age requirement
• Receiving first-line chemotherapy with doxorubicin 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
Change in ctDNA with RECIST	4 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).

Secondary Outcome Measures

Name	Time	Method
Frequency of ctDNA in patients with unresectable or metastatic leiomyosarcoma.	4 years from study start	Plasma collections for ctDNA analysis will be collected at each subsequent early time-point (pre-cycle 1 and pre-cycle 2).

Trial Locations

Locations (10)

Sarcoma Oncology Research Center; 🇺🇸 Santa Monica, California, United States

Dana- Farber; 🇺🇸 Boston, Massachusetts, United States

University of Michigan Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

MD Anderson; 🇺🇸 Houston, Texas, United States

Chris O'Brien Lifehouse; 🇦🇺 Camperdown, New South Wales, Australia

Peter MacCallum Cancer Centre; 🇦🇺 Melbourne, Victoria, Australia