Localized Leiomyosarcoma Biomarker Protocol

Leiomyosarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04925089
• Other study ID #: HUM00219057
• Secondary ID: HUM002137231P50C
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Leiomyosarcoma

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