Trial Title:
Metastatic Leiomyosarcoma Biomarker Protocol
NCT ID:
NCT05653388
Condition:
Leiomyosarcoma
Conditions: Official terms:
Leiomyosarcoma
Conditions: Keywords:
ctDNA
Biomarker
radiomics
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Plasma Collection
Description:
Patients will provide tissue and blood samples. No medical intervention will be completed
for study purposes
Arm group label:
Enrolled Subjects
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.
Criteria for eligibility:
Study pop:
Patients with unresectable or metastatic leiomyosarcoma
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dana- Farber
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
David Shulman, MD
Facility:
Name:
University of Michigan Cancer Center
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Scott Schuetze, M.D., PhD.
Phone:
734-647-8925
Investigator:
Last name:
Scott Schuetze, M.D., PhD
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55901
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brittany Siontis, MD
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sujana Movva, MD
Facility:
Name:
Ohio State University
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gabriel Tinoco, MD
Facility:
Name:
Vanderbilt University Medical Center
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elizabeth J Davis, MD
Phone:
615-322-5000
Facility:
Name:
MD Anderson
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elise Nassif Haddad, MD, PhD
Phone:
281-460-0607
Email:
efnassif@mdanderson.org
Facility:
Name:
Chris O'Brien Lifehouse
Address:
City:
Camperdown
Zip:
2050
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Peter Grimison
Email:
Peter.grimison@lh.org.au
Facility:
Name:
Centre for Molecular Oncology
Address:
City:
Sydney
Zip:
2052
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Mandy Ballinger
Facility:
Name:
Peter MacCallum Cancer Centre
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Stephen Luen
Email:
stephen.luen@petermac.org
Start date:
December 22, 2022
Completion date:
December 2026
Lead sponsor:
Agency:
University of Michigan Rogel Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Michigan Rogel Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05653388
