Leukemia, Myelogenous, Chronic
Conditions
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.
Interventions
DEVICEXpert BCR-ABL Ultra
Semi-quantitation of BCR-ABL transcript in patients that have been previously diagnosed with CML
Sponsors
Cepheid
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Method comparison to an on-market molecular diagnostic assay | Baseline = testing upon enrollment | Comparison of Xpert to an on-market test for the quantitation of BCR-ABL |
Countries
United States
Outcome results
None listed