Metastatic Leiomyosarcoma Biomarker Protocol

Leiomyosarcoma Clinical Trial

Official title:

Observational Study of Biomarkers of Disease-related Outcomes in Patients With Metastatic Leiomyosarcoma Receiving Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05653388
• Other study ID #: HUM00216516
• Secondary ID: 1P50CA272170-01H
• Status: Recruiting
• Start date: December 22, 2022
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: University of Michigan Rogel Cancer Center
• Contact: Scott Schuetze
• Phone: 734-647-8921
• Email: scotschu[@]med.umich.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Leiomyosarcoma (LMS) is one of the most prevalent soft tissue sarcomas (STS) and can occur in various sites including soft tissue, uterus and retroperitoneal large vessels. Metastatic disease occurs in approximately 50% of patients diagnosed with leiomyosarcoma and prognosis is poor in setting of metastatic disease. A minority of patients benefit from treatment with chemotherapy and early biomarkers of benefit from treatment are lacking. 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. Circulating tumor DNA (ctDNA) is present in blood of patients with advanced/metastatic cancer and may serve as biomarker of tumor response to chemotherapy. Blood samples will be collected prior to and during and 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. Study participants will be asked to complete a questionnaire on attitudes and understanding of genetics and genetic testing.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with unresectable or metastatic leiomyosarcoma (LMS). There is no age requirement

• Receiving first-line chemotherapy with doxorubicin or gemcitabine/docetaxel

• Sum of target lesions per RECIST1.1 of 5 cm or greater

• Archival tumor tissue including 1 H&E stained slide and unstained tumor tissue (either tissue block containing tumor, or minimum of 4 unstained slides - fresh frozen sample may also be used in lieu of FFPE sample) available for study research

Related Conditions & MeSH terms

• Leiomyosarcoma

Intervention

Other:
• Plasma Collection
Patients will provide tissue and blood samples. No medical intervention will be completed for study purposes

Locations

Country	Name	City	State
United States	University of Michigan Cancer Center	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	Change in ctDNA with RECIST	To examine the correlation of change in ctDNA with objective tumor response per RECIST. Analysis will occur at each subsequent early time-point (pre-cycle 1, mid-cycle 1 and pre-cycle 2).	4 years from study start
Primary	Change in ctDNA with progression free survival (PFS)	To examine the correlation of change in ctDNA with progression free survival (PFS). Analysis of ctDNA will occur at each subsequent early time-point (pre-cycle 1, mid-cycle 1 and pre-cycle 2). A Cox regression model will determine whether the baseline ctDNA levels are associated with PFS.	54 months from study start
Secondary	Frequency of ctDNA in patients with unresectable or metastatic leiomyosarcoma.	Plasma collections for ctDNA analysis will be collected at each subsequent early time-point (pre-cycle 1, mid-cycle 1 and pre-cycle 2).	4 years from study start