Recruiting

Observational Study

Sponsor:

University of Michigan Rogel Cancer Center

Code:

NCT04925089

Conditions

Leiomyosarcoma

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Blood and Tissue collection

Study Details

Brief summary:

  • Leiomyosarcoma (LMS) is one of the more common soft tissue sarcomas (STS).
  • Patients presenting with large, high-grade, localized LMS are at significant risk of developing metastasis following curative surgery.
  • Clinical trials of neoadjuvant or adjuvant anthracycline and ifosfamide have suggested that patients with localized STS who are at high-risk of metastasis may benefit from chemotherapy, but the magnitude of benefit in unselected patient population is relatively small.
  • Currently, patient age, and tumor size and grade are used to assess risk of metastases and survival
  • Studies evaluating tumor response by imaging and histopathology have not established correlation between tumor characteristics as biomarkers for risk of metastasis or sarcoma recurrence.
  • Circulating tumor DNA (ctDNA) is present in blood of patients with advanced/metastatic LMS and may serve as biomarker of tumor response to chemotherapy. Blood samples will be collected prior to, during and after 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. Patients will be followed for 2 years after study entry for signs of sarcoma recurrence.
  • 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.

Conditions

Leiomyosarcoma

Study ID

NCT04925089

Start date

Apr 26, 2023

Status verified date

Jul, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with localized leiomyosarcoma (LMS) of extremity, body wall or retroperitoneum
  • Grade 2 or 3, or high-grade LMS
  • Tumor size >5 cm in greatest dimension
  • Primary tumor amenable to complete resection
  • There is no age requirement
  • Participant agrees to receive neoadjuvant doxorubicin and ifosfamide combination chemotherapy
  • If pre-operative radiation is administered, it must be administered after chemotherapy. Post-operative radiation may be administered
  • Archival tumor tissue (either frozen sample, tissue block containing tumor, or minimum of 4 unstained slides and 1 H\&E stained slide) from diagnostic or pre-treatment biopsy available for study research

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Interventions

Blood and Tissue collection

Blood and tissue will be collected and analyzed for detection of ctDNA and genetic change

Primary outcome measure

  • To evaluate the association between tumor characteristics assessed by contrast-enhanced MRI and location with presence of circulating tumor DNA (ctDNA) in patients with localized, high-grade leiomyosarcoma [ Time Frame: 2 years ]
  • To evaluate change in ctDNA in patients with localized, high-grade leiomyosarcoma undergoing preoperative doxorubicin/ifosfamide chemotherapy with or without pre-operative radiation [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Scott Schuetze

7346478921scotschu@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Scott Schuetze, MD/PhD

734-647-8925

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55901

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Elizabeth J Davis, MD

615-322-5000

More Information

Sponsor

University of Michigan Rogel Cancer Center

Last update posted

Jul 2, 2026

Last verified

Jul, 2026

Keywords

  • ctDNA
  • radiomics
  • biomarker

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan Rogel Cancer Center on 2026-07-02.