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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04925089
Other study ID # HUM00219057
Secondary ID HUM002137231P50C
Status Recruiting
Phase
First received
Last updated
Start date April 26, 2023
Est. completion date April 2025

Study information

Verified date May 2024
Source University of Michigan Rogel Cancer Center
Contact Scott Schuetze
Phone 7346478921
Email scotschu@med.umich.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date April 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Blood and Tissue collection
Blood and tissue will be collected and analyzed for detection of ctDNA and genetic change

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan
United States Vanderbilt University Medical Center Nashville Tennessee
United States Memorial Sloan Kettering Cancer Center New York New York
United States Mayo Clinic Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan Rogel Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 leiomyosarcoma Tumor characteristics from imaging will be compared to the presence of circulating tumor DNA , obtained from blood samples over multiple time points 2 years
Primary To evaluate change in ctDNA in patients with localized, high-grade leiomyosarcoma undergoing preoperative doxorubicin/ifosfamide chemotherapy with or without pre-operative radiation 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 2 years
Secondary To examine the association of change in ctDNA and imaging characteristics with 2-year relapse-free survival The change in the presence of ctDNA from serial blood collection will be compared to the absence of sarcoma recurrence or after 2 years 2 years
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