RecruitingNCT04925089

Localized Leiomyosarcoma Biomarker Protocol

Pilot Study of ctDNA and Imaging Characteristics as Biomarkers of Disease-related Outcomes in Patients With Localized Leiomyosarcoma Receiving Chemotherapy


Sponsor

University of Michigan Rogel Cancer Center

Enrollment

40 participants

Start Date

Apr 26, 2023

Study Type

OBSERVATIONAL

Conditions

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

Plain Language Summary

Simplified for easier understanding

This study is collecting tumor samples and tracking outcomes in patients with localized leiomyosarcoma (LMS, a type of soft tissue cancer in muscle) of the arm, leg, or abdomen who are receiving chemotherapy before surgery, aiming to identify biological markers that predict treatment response. **You may be eligible if:** - You have a confirmed diagnosis of leiomyosarcoma located in an extremity, body wall, or retroperitoneum (belly area) - Your tumor is grade 2 or 3 (intermediate to high grade) and larger than 5 cm - Your tumor can be completely removed with surgery - You agree to receive doxorubicin and ifosfamide chemotherapy before surgery - Pre-treatment biopsy tissue is available - There is no specific age requirement **You may NOT be eligible if:** - Your tumor is low grade or too small - Your tumor cannot be completely removed surgically - You are not willing to receive the specified pre-operative chemotherapy regimen Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBlood and Tissue collection

Blood and tissue will be collected and analyzed for detection of ctDNA and genetic change


Locations(3)

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

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NCT04925089


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