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NCT Number: NCT05653388

Metastatic Leiomyosarcoma Biomarker Protocol

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Plasma Collection

Other

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

Primary outcomes

  1. Change in ctDNA with RECIST

    Time frame: 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).

  2. Change in ctDNA with progression free survival (PFS)

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Scott Schuetze

CONTACT

[email protected]

734-647-8921

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2022
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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