NCT04925089 Localized Leiomyosarcoma Biomarker Protocol
| NCT ID | NCT04925089 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan Rogel Cancer Center |
| Condition | Leiomyosarcoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-04-26 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2023-04-26 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 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 & Investigator
Scott Schuetze
PRINCIPAL INVESTIGATOR
University of Michigan Rogal Cancer Center
Frequently Asked Questions
Who can join the NCT04925089 clinical trial?
This trial is open to participants of all sexes, studying Leiomyosarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04925089 currently recruiting?
Yes, NCT04925089 is actively recruiting participants. Contact the research team at scotschu@med.umich.edu for enrollment information.
Where is the NCT04925089 trial being conducted?
This trial is being conducted at Ann Arbor, United States, Rochester, United States, Nashville, United States.
Who is sponsoring the NCT04925089 clinical trial?
NCT04925089 is sponsored by University of Michigan Rogel Cancer Center. The principal investigator is Scott Schuetze at University of Michigan Rogal Cancer Center. The trial plans to enroll 40 participants.