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Metastatic Leiomyosarcoma Biomarker Protocol

NCT05653388 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-12-26

No results posted yet for this 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.

Conditions

  • Leiomyosarcoma

Interventions

OTHER

Plasma Collection

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Scott Schuetze · University of Michigan Rogel Cancer Center

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-22
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05653388 on ClinicalTrials.gov