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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05653388
Other study ID # HUM00216516
Secondary ID 1P50CA272170-01H
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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