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RecruitingObservational

Observational Study of Biomarkers of Disease-related Outcomes in Patients With Metastatic Leiomyosarcoma Receiving Chemotherapy

NCT ID: NCT05653388Sponsor: University of Michigan Rogel Cancer CenterLast updated: 2025-12-26

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.

Arms & interventions

  • OtherPlasma Collection

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

Outcome measures

Primary

  • 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).

    Time frame: 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.

    Time frame: 54 months from study start

Secondary

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

    Time frame: 4 years from study start

Eligibility criteria

Sex: AllAge: All agesHealthy volunteers: No
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 locations (9)

Sarcoma Oncology Research Center

Santa Monica, California, 90403

Recruiting
Sant P Chawla, MD · Principal Investigator

University of Miami

Miami, Florida, 33136

Recruiting
Gina D'Amato, MD · Contact
Gina D'Amato, MD · Principal Investigator

Dana- Farber

Boston, Massachusetts, 02215

Recruiting
David Shulman, MD · Contact

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109

Recruiting
Scott Schuetze, M.D., PhD. · Contact
Scott Schuetze, M.D., PhD · Principal Investigator

Mayo Clinic

Rochester, Minnesota, 55901

Recruiting
Brittany Siontis, MD · Contact

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting
Sujana Movva, MD · Contact

Ohio State University

Columbus, Ohio, 43210

Recruiting
Gabriel Tinoco, MD · Contact

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

Recruiting
Elizabeth J Davis, MD · Contact

MD Anderson

Houston, Texas, 77030

Recruiting
Elise Nassif Haddad, MD, PhD · Contact