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Metastatic Leiomyosarcoma Biomarker Protocol

N/A
Recruiting
Led By Scott Schuetze
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years from study start
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Leiomyosarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years from study start
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years from study start for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in ctDNA with RECIST
Change in ctDNA with progression free survival (PFS)
Secondary study objectives
Frequency of ctDNA in patients with unresectable or metastatic leiomyosarcoma.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Enrolled SubjectsExperimental Treatment1 Intervention
Once enrolled subjects will provide Optional Archival Tissue, Optional Fresh tumor for a biopsy and blood collections at baseline, optional day 8 of cycle 1, day 1 of cycles 2-6 and at progression

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
300 Previous Clinical Trials
21,035 Total Patients Enrolled
1 Trials studying Leiomyosarcoma
40 Patients Enrolled for Leiomyosarcoma
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,111,897 Total Patients Enrolled
45 Trials studying Leiomyosarcoma
4,653 Patients Enrolled for Leiomyosarcoma
Scott SchuetzePrincipal InvestigatorUniversity of Michigan Rogel Cancer Center
2 Previous Clinical Trials
80 Total Patients Enrolled
1 Trials studying Leiomyosarcoma
40 Patients Enrolled for Leiomyosarcoma
~98 spots leftby Dec 2026