Observational Study for Localized Leiomyosarcoma
This study is looking at people with localized leiomyosarcoma (a type of soft tissue cancer) that is high-grade and larger than 5 cm. We want to understand if changes in circulating tumor DNA (ctDNA), which are tiny pieces of cancer DNA in your blood, are linked to how your tumor looks on an MRI scan. We're also studying how ctDNA levels change in patients receiving chemotherapy with doxorubicin and ifosfamide, sometimes with radiation, before surgery. This study is for patients whose tumor can be completely removed and who agree to receive this specific chemotherapy. We hope to find better ways to predict how leiomyosarcoma will behave. The current status of this study is unclear.
- Study design
- This is an observational study, meaning researchers will collect information without giving new treatments. It plans to enroll 40 participants.
- What's involved
- Blood and tissue samples will be collected and analyzed. Participants will receive neoadjuvant doxorubicin and ifosfamide combination chemotherapy.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 2 years to evaluate the study's main goals.
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Localized Leiomyosarcoma Biomarker Protocol
At a glance
Conditions
Where it's being run
3 sites across 3 statesStudy leadership
- Scott Schuetze · PRINCIPAL_INVESTIGATOR · University of Michigan Rogal Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- To evaluate the association between tumor characteristics assessed by contrast-enhanced MRI and location with presence of circulating tumor DNA (ctDNA) in patients with localized, high-grade leiomyosarcoma2 years
Tumor characteristics from imaging will be compared to the presence of circulating tumor DNA , obtained from blood samples over multiple time points
- To evaluate change in ctDNA in patients with localized, high-grade leiomyosarcoma undergoing preoperative doxorubicin/ifosfamide chemotherapy with or without pre-operative radiation2 years
Blood will be collected at multiple timepoints. The presence of ctDNA will be assessed prior to, during, and after treatment with chemotherapy and / or radiation