NCT04925089Recruiting
Localized Leiomyosarcoma Biomarker Protocol
Pilot Study of ctDNA and Imaging Characteristics as Biomarkers of Disease-related Outcomes in Patients With Localized Leiomyosarcoma Receiving Chemotherapy
Source: ClinicalTrials.gov · Last updated 2 Jul 2026
Brief summary (registry, in English)
* 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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 8 Jun 2021
- Start date
- 26 Apr 2023
- Primary completion date
- Nov 2026
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT04925089
What you commit to
- Study type: Observational
- Planned participants: 40
- From 26 Apr 2023 to the primary completion date, Nov 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.