Metastatic Leiomyosarcoma Biomarker Protocol

NCT05653388 | Recruiting

• 3 other identifiers: HUM002165161P50CA272170-01HUM00219342
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 11

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.

Conditions

Leiomyosarcoma

Keywords

ctDNA; Biomarker; radiomics

Outcome Measures

Primary Outcomes (2)

• Change in ctDNA with RECIST

  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).

  4 years from study start

• Change in ctDNA with progression free survival (PFS)

  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.

  54 months from study start

Secondary Outcomes (1)

• Frequency of ctDNA in patients with unresectable or metastatic leiomyosarcoma.

  4 years from study start

Study Arms (1)

Enrolled Subjects

Once enrolled subjects will provide Optional Archival Tissue, Optional Fresh tumor for a biopsy and blood collections at baseline, optional day 8 of cycle 1, day 1 of cycles 2-6 and at progression

Other: Plasma Collection

Interventions

Plasma Collection OTHER

Patients will provide tissue and blood samples. No medical intervention will be completed for study purposes

Enrolled Subjects

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with unresectable or metastatic leiomyosarcoma

You may qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (11)

Sarcoma Oncology Research Center

Santa Monica, California, 90403, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Dana- Farber

Boston, Massachusetts, 02215, United States

RECRUITING

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55901, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MD Anderson

Houston, Texas, 77030, United States

RECRUITING

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Optional Archival Tissue, Optional Fresh tumor biopsy, blood collections prior to day 1 of first chemotherapy, optional day 8 of cycle 1, day 1 of cycles 2-6 and at progression of sarcoma

MeSH Terms

Conditions

Leiomyosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Officials

• Scott Schuetze

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott Schuetze

CONTACT

734-647-8921; scotschu@med.umich.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 16, 2022
• Study Start: December 22, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At the end of the study
• Access Criteria: We will share deidentified genetic data on the NIH site, and deidentified imaging data will be shared with the lab at Columbia University. We are not sharing patient identities.

Locations

AU (2); US (9)