Trials / Completed
CompletedNCT03421626
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 266 (actual)
- Sponsor
- Cepheid · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Xpert BCR-ABL Ultra | Semi-quantitation of BCR-ABL transcript in patients that have been previously diagnosed with CML |
Timeline
- Start date
- 2017-11-08
- Primary completion
- 2018-08-20
- Completion
- 2018-08-20
- First posted
- 2018-02-05
- Last updated
- 2019-04-16
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03421626. Inclusion in this directory is not an endorsement.