Clinical Evaluation of a Test for Monitoring Patients Diagnosed With Chronic Myeloid Leukemia (CML)
Clinical Evaluation of the Xpert BCR-ABL Ultra Assay on the GeneXpert Instrument Systems
1 other identifier
observational
266
1 country
7
Brief Summary
The objective of this study is to establish the performance of an assay that detects mRNA transcript levels in patients diagnosed with CML. The study is conducted at locations within the United States. Testing is performed on peripheral blood specimens provided by eligible enrolled patients. Results from this study will not be used for patient management decisions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2017
Shorter than P25 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 8, 2017
CompletedFirst Submitted
Initial submission to the registry
January 30, 2018
CompletedFirst Posted
Study publicly available on registry
February 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2018
CompletedApril 16, 2019
January 1, 2018
10 months
January 30, 2018
April 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Method comparison to an on-market molecular diagnostic assay
Comparison of Xpert to an on-market test for the quantitation of BCR-ABL
Baseline = testing upon enrollment
Study Arms (1)
Primary Enrollment
Initial enrollment of patients with history of CML
Interventions
Semi-quantitation of BCR-ABL transcript in patients that have been previously diagnosed with CML
Eligibility Criteria
Males and females at least 18 years of age who were previously diagnosed with CML from primary care clinics.
You may qualify if:
- prospective specimens:
- Patient is at least 18 years of age
- Patient has provided documented informed consent as required by the reviewing IRB. Experimental Bill of Rights will also be documented for all subjects enrolled in applicable states.
- Patient has been diagnosed with CML.
- Patient consents to provide at least 12 mL of peripheral blood for study purposes
- frozen specimens:
- Specimen is from a subject diagnosed with CML
- Specimen meets the manufacturer's criteria to support testing by both diagnostic assays
You may not qualify if:
- prospective specimens:
- Patient is considered to be of insufficient health to supply the required volume of peripheral blood by his/her health care provider
- Patient has been previously enrolled
- frozen specimens: • Specimen previously enrolled
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cepheidlead
Study Sites (7)
Broward Oncology Associates
Fort Lauderdale, Florida, 33308, United States
St. Alphonsus Regional Medical Center
Boise, Idaho, 83706, United States
WJB Dorn VA Medical Center
Columbia, South Carolina, 29209, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
United Hospital Center
Bridgeport, West Virginia, 26330, United States
St. Mary's Medical Center
Huntington, West Virginia, 25702, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2018
First Posted
February 5, 2018
Study Start
November 8, 2017
Primary Completion
August 20, 2018
Study Completion
August 20, 2018
Last Updated
April 16, 2019
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share