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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05653388
Registration number
NCT05653388
Ethics application status
Date submitted
7/12/2022
Date registered
16/12/2022
Date last updated
26/06/2024
Titles & IDs
Public title
Metastatic Leiomyosarcoma Biomarker Protocol
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Scientific title
Observational Study of Biomarkers of Disease-related Outcomes in Patients With Metastatic Leiomyosarcoma Receiving Chemotherapy
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Secondary ID [1]
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1P50CA272170-01
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Secondary ID [2]
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HUM00216516
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Leiomyosarcoma
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Condition category
Condition code
Cancer
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Sarcoma (also see 'Bone') - soft tissue
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - Plasma Collection
Enrolled Subjects - Once enrolled subjects will provide Archival Tissue, Optional Fresh tumor from a biopsy and blood collections at baseline, day 8 of cycle 1, day 1 of cycles 2-6, and at progression.
Other interventions: Plasma Collection
Patients will provide tissue and blood samples. No medical intervention will be completed for study purposes
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in ctDNA with RECIST
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Assessment method [1]
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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).
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Timepoint [1]
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4 years from study start
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Primary outcome [2]
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Change in ctDNA with progression free survival (PFS)
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Assessment method [2]
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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.
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Timepoint [2]
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54 months from study start
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Secondary outcome [1]
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Frequency of ctDNA in patients with unresectable or metastatic leiomyosarcoma.
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Assessment method [1]
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Plasma collections for ctDNA analysis will be collected at each subsequent early time-point (pre-cycle 1, mid-cycle 1 and pre-cycle 2).
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Timepoint [1]
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4 years from study start
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Eligibility
Key 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
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/12/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2026
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,UNSWVIC
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Recruitment hospital [1]
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Chris O'Brien Lifehouse - Camperdown
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Recruitment hospital [2]
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Centre for Molecular Oncology - Sydney
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Recruitment hospital [3]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2052 - Sydney
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Recruitment postcode(s) [3]
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3000 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Massachusetts
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Country [2]
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United States of America
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State/province [2]
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Michigan
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Country [3]
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United States of America
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Minnesota
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United States of America
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State/province [4]
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New York
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Country [5]
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United States of America
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State/province [5]
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Ohio
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Country [6]
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United States of America
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State/province [6]
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Tennessee
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Country [7]
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United States of America
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State/province [7]
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Texas
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Michigan Rogel Cancer Center
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Address
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Other collaborator category [1]
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Government body
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Name [1]
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National Cancer Institute (NCI)
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT05653388
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Scott Schuetze
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Address
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University of Michigan Rogel Cancer Center
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Scott Schuetze
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Address
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Country
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Phone
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734-647-8921
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT05653388
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