Localized Leiomyosarcoma Biomarker Protocol

May 7, 2024 updated by: University of Michigan Rogel Cancer Center

Pilot Study of ctDNA and Imaging Characteristics as Biomarkers of Disease-related Outcomes in Patients With Localized Leiomyosarcoma Receiving Chemotherapy

  • 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
          • Scott Schuetze, MD/PhD
          • Phone Number: 734-647-8925
    • Minnesota
      • Rochester, Minnesota, United States, 55901
        • Not yet recruiting
        • Mayo Clinic
        • Contact:
          • Brittany Siontis, MD
    • New York
      • New York, New York, United States, 10065
        • Not yet recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Sujana Movva, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Not yet recruiting
        • Vanderbilt University Medical Center
        • Contact:
          • Elizabeth J Davis, MD
          • Phone Number: 615-322-5000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Tumor characteristics from imaging will be compared to the presence of circulating tumor DNA , obtained from blood samples over multiple time points
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
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To examine the association of change in ctDNA and imaging characteristics with 2-year relapse-free survival
Time Frame: 2 years
The change in the presence of ctDNA from serial blood collection will be compared to the absence of sarcoma recurrence or after 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan Rogel Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Scott Schuetze, University of Michigan Rogal Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2023

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

June 11, 2021

First Posted (Actual)

June 14, 2021

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00219057
  • HUM00213723 (Other Identifier: University of Michigan)
  • 1P50CA272170-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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