Status:
COMPLETED
Clinical Evaluation of a Test for Monitoring Patients Diagnosed With Chronic Myeloid Leukemia (CML)
Lead Sponsor:
Cepheid
Conditions:
Leukemia, Myelogenous, Chronic
Eligibility:
All Genders
18-100 years
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 8 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 20 2018
Estimated Enrollment :
266 Patients enrolled
Trial Details
Trial ID
NCT03421626
Start Date
November 8 2017
End Date
August 20 2018
Last Update
April 16 2019
Active Locations (7)
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1
Broward Oncology Associates
Fort Lauderdale, Florida, United States, 33308
2
St. Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
3
WJB Dorn VA Medical Center
Columbia, South Carolina, United States, 29209
4
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109