Metastatic Leiomyosarcoma Biomarker Protocol

Last updated: December 3, 2024
Sponsor: University of Michigan Rogel Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sarcoma

Infantile Fibrosarcoma

Sarcoma (Pediatric)

Treatment

Plasma Collection

Clinical Study ID

NCT05653388
HUM00216516
HUM00219342
1P50CA272170-01
HUM00216516
  • All Genders

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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Plasma Collection
Phase:
Study Start date:
December 22, 2022
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • Centre for Molecular Oncology

    Sydney, UNSW 2052
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • Dana- Farber

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • University of Michigan Cancer Center

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55901
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • MD Anderson

    Houston, Texas 77030
    United States

    Active - Recruiting

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