Localized Leiomyosarcoma Biomarker Protocol
Pilot Study of ctDNA and Imaging Characteristics as Biomarkers of Disease-related Outcomes in Patients With Localized Leiomyosarcoma Receiving Chemotherapy
3 other identifiers
observational
40
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2023
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2021
CompletedFirst Posted
Study publicly available on registry
June 14, 2021
CompletedStudy Start
First participant enrolled
April 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
February 17, 2026
February 1, 2026
3.1 years
June 8, 2021
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
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 Outcomes (1)
To examine the association of change in ctDNA and imaging characteristics with 2-year relapse-free survival
2 years
Interventions
Blood and tissue will be collected and analyzed for detection of ctDNA and genetic change
Eligibility Criteria
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
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Mayo Clinic
Rochester, Minnesota, 55901, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Related Publications (1)
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.
PMID: 35412607DERIVED
Biospecimen
Blood will be obtained after enrollment for analysis of germ-line DNA and for ctDNA. Archival tissue will be collected and analyzed for gene mutations in leiomyosarcoma. Tumor tissue from sarcoma resection will be collected and analyzed for genetic changes in leiomyosarcoma after treatment. Digital Images will be collected and analyzed for change in imaging characteristics.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Schuetze
University of Michigan Rogal Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2021
First Posted
June 14, 2021
Study Start
April 26, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
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.