Biomarker study for localized leiomyosarcoma
Pilot Study of ctDNA and Imaging Characteristics as Biomarkers of Disease-related Outcomes in Patients With Localized Leiomyosarcoma Receiving Chemotherapy
University of Michigan Rogel Cancer Center · NCT04925089
This study is testing if a blood test for tumor DNA can help predict how well chemotherapy works for people with localized leiomyosarcoma who are at high risk of their cancer spreading after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Sex | All |
| Sponsor | University of Michigan Rogel Cancer Center (other) |
| Drugs / interventions | chemotherapy, radiation, doxorubicin |
| Locations | 3 sites (Ann Arbor, Michigan and 2 other locations) |
| Trial ID | NCT04925089 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with localized leiomyosarcoma (LMS) who are at high risk of metastasis following surgery. It aims to evaluate circulating tumor DNA (ctDNA) as a potential biomarker for tumor response to chemotherapy. Blood samples will be collected from participants before, during, and after receiving neoadjuvant chemotherapy with doxorubicin and ifosfamide. The study will also analyze archival tumor tissue to correlate with ctDNA findings and assess the risk of metastasis and recurrence.
Who should consider this trial
Good fit: Ideal candidates include patients with high-grade localized leiomyosarcoma of the extremity, body wall, or retroperitoneum, with tumors larger than 5 cm.
Not a fit: Patients with low-grade tumors or those whose tumors are not amenable to complete resection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the ability to predict metastasis and tailor chemotherapy for patients with localized leiomyosarcoma.
How similar studies have performed: Other studies have explored the use of ctDNA in various cancers, showing promising results, but this specific approach in localized LMS is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ann Arbor, Michigan and 2 other locations
- University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)
- Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)
Study contacts
- Principal investigator: Scott Schuetze — University of Michigan Rogal Cancer Center
- Study coordinator: Scott Schuetze
- Email: scotschu@med.umich.edu
- Phone: 7346478921
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Leiomyosarcoma, ctDNA, radiomics, biomarker