Metastatic Leiomyosarcoma Biomarker Protocol
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Plasma Collection.
- Who it may be relevant to
- Registry conditions: Leiomyosarcoma. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Observational Study of Biomarkers of Disease-related Outcomes in Patients With Metastatic Leiomyosarcoma Receiving Chemotherapy
Overview
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.
Interventions
- Other Plasma Collection
Patients will provide tissue and blood samples. No medical intervention will be completed for study purposes
Primary outcome measures
- Change in ctDNA with RECIST [Time frame: 4 years from study start]
- Change in ctDNA with progression free survival (PFS) [Time frame: 54 months from study start]
Secondary outcome measures (1)
- Frequency of ctDNA in patients with unresectable or metastatic leiomyosarcoma. [Time frame: 4 years from study start]
Eligibility criteria
Inclusion criteria
- Patients with unresectable or metastatic leiomyosarcoma (LMS). There is no age requirement
- Receiving first-line chemotherapy with doxorubicin- based or gemcitabine/docetaxel
- Target lesions per RECIST 1.1
- Optional archival tumor tissue including 1 H\&E-stained slide and unstained tumor tissue \[either tissue block containing tumor, or minimum of 4 unstained slides (preferably 8 unstained slides)-fresh frozen sample may also be used in lieu of FFPE sample\] available for study research
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 9 centers
- Sarcoma Oncology Research Center — Santa Monica
- University of Miami — Miami
- Dana- Farber — Boston
- University of Michigan Cancer Center — Ann Arbor
- Mayo Clinic — Rochester
- Memorial Sloan Kettering Cancer Center — New York
- Ohio State University — Columbus
- Vanderbilt University Medical Center — Nashville
- … and 1 more center
Australia · 2 centers
- Chris O'Brien Lifehouse — Camperdown
- Peter MacCallum Cancer Centre — Melbourne
Identifiers
NCT: NCT05653388 · HUM00216516 · 1P50CA272170-01 · HUM00219342 · HUM00216516