NCT05653388 Metastatic Leiomyosarcoma Biomarker Protocol
| NCT ID | NCT05653388 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan Rogel Cancer Center |
| Condition | Leiomyosarcoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-12-22 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 200 participants in total. It began in 2022-12-22 with a primary completion date of 2026-12.
⚠ 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 most prevalent soft tissue sarcomas (STS) and can occur in various sites including soft tissue, uterus and retroperitoneal large vessels. Metastatic disease occurs in approximately 50% of patients diagnosed with leiomyosarcoma and prognosis is poor in setting of metastatic disease. A minority of patients benefit from treatment with chemotherapy and early biomarkers of benefit from treatment are lacking. 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. Circulating tumor DNA (ctDNA) is present in blood of patients with advanced/metastatic cancer and may serve as biomarker of tumor response to chemotherapy. Blood samples will be collected prior to and during and 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. Study participants will be asked to complete a questionnaire on attitudes and understanding of genetics and genetic testing.
Eligibility Criteria
Inclusion Criteria: * Patients with unresectable or metastatic leiomyosarcoma (LMS). There is no age requirement * Receiving first-line chemotherapy with doxorubicin- based or gemcitabine/docetaxel * Target lesions per RECIST 1.1 * Optional archival tumor tissue including 1 H\&E-stained slide and unstained tumor tissue \[either tissue block containing tumor, or minimum of 4 unstained slides (preferably 8 unstained slides)-fresh frozen sample may also be used in lieu of FFPE sample\] available for study research
Contact & Investigator
Scott Schuetze
PRINCIPAL INVESTIGATOR
University of Michigan Rogel Cancer Center
Frequently Asked Questions
Who can join the NCT05653388 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 NCT05653388 currently recruiting?
Yes, NCT05653388 is actively recruiting participants. Contact the research team at scotschu@med.umich.edu for enrollment information.
Where is the NCT05653388 trial being conducted?
This trial is being conducted at Santa Monica, United States, Miami, United States, Boston, United States, Ann Arbor, United States and 7 additional locations.
Who is sponsoring the NCT05653388 clinical trial?
NCT05653388 is sponsored by University of Michigan Rogel Cancer Center. The principal investigator is Scott Schuetze at University of Michigan Rogel Cancer Center. The trial plans to enroll 200 participants.