Metastatic Leiomyosarcoma Biomarker Protocol
ConditionLeiomyosarcoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Michigan Rogel Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
Patients with unresectable or metastatic leiomyosarcoma
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Plasma Collection
Other interventionPatients will provide tissue and blood samples. No medical intervention will be completed for study purposes
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Enrolled Subjects1 intervention
Trial outcomes
Primary outcomes
1
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 and pre-cycle 2).
Time frame
4 years from study start2
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 and pre-cycle 2). A Cox regression model will determine whether the baseline ctDNA levels are associated with PFS.
Time frame
54 months from study startSecondary outcomes
1
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 and pre-cycle 2).
Time frame
4 years from study startSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan Rogel Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov