ClinicalTrials.gg
RecruitingNCT04925089Updated Jul 2, 2026

Localized Leiomyosarcoma Biomarker Protocol

An observational study in Leiomyosarcoma, sponsored by University of Michigan Rogel Cancer Center. Recruiting at 3 sites in United States. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by University of Michigan Rogel Cancer Center · Observational

From the registry’s dates

  • Started Apr 2023; still recruiting 3 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Sex
All
01

Study 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.
02

Conditions studied

  • Leiomyosarcoma

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Keywords

  • ctDNA
  • radiomics
  • biomarker
03

In context

Leiomyosarcoma

177 studies on the registry are indexed under Leiomyosarcoma; 35 are open to participants now.

This study's planned enrollment of 40 is below the median of 250 across 15 observational studies indexed under Leiomyosarcoma.

Browse Leiomyosarcoma studies →

Lead sponsor

University of Michigan Rogel Cancer Center is the lead sponsor of 323 studies on the registry; 47 are open to participants now.

Of its 46 completed or terminated interventional studies of FDA-regulated products, 31 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who have been diagnosed with grade 2 or 3, high-grade leiomyosarcoma who have agreed to receive neoadjuvant doxorubicin and ifosfamide combination chemotherapy where the primary tumor is amenable to complete resection

Eligibility criteria

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 doxorubicin and ifosfamide combination chemotherapy
  • If pre-operative radiation is administered, it must be administered after chemotherapy. Post-operative radiation may be administered
  • (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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • OtherBlood and Tissue collection

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

06

What researchers measure

Primary outcomes

  1. 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

    Tumor characteristics from imaging will be compared to the presence of circulating tumor DNA , obtained from blood samples over multiple time points

    Time frame: 2 years

  2. To evaluate change in ctDNA in patients with localized, high-grade leiomyosarcoma undergoing preoperative doxorubicin/ifosfamide chemotherapy with or without pre-operative radiation

    Blood will be collected at multiple timepoints. The presence of ctDNA will be assessed prior to, during, and after treatment with chemotherapy and / or radiation

    Time frame: 2 years

Secondary outcomes

  1. To examine the association of change in ctDNA and imaging characteristics with 2-year relapse-free survival

    The change in the presence of ctDNA from serial blood collection will be compared to the absence of sarcoma recurrence or after 2 years

    Time frame: 2 years

07

Study locations

3 of 3 sites recruiting
08

References and documents

Publications

  • Kasper B, Wilky BA. Sounding the Alarm on Leiomyosarcoma Recurrence: Role of Circulating Tumor DNA. Clin Cancer Res. 2022 Jun 13;28(12):2480-2481. doi: 10.1158/1078-0432.CCR-22-0738. PubMed 35412607 ↗

Individual participant data

Plan to share: No — We will share deidentified genetic data on the NIH site, and deidentified imaging data will be shared with the lab at Columbia University. We are not sharing patient identities.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04925089
Responsible party
Sponsor
First posted
Jun 14, 2021
Start date
Apr 26, 2023
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Jul 2, 2026

Study contacts

Scott Schuetze
Contact
scotschu@med.umich.edu
7346478921
Scott Schuetze
principal investigator · University of Michigan Rogal Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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