Cancer Leukemia-CML
| Title: | Clinical Evaluation of the Xpert® BCR-ABL Ultra Assay on the GeneXpert® Instrument System – Protocol 231 |
| Description: | Cepheid is making a rapid molecular diagnostic test for the detection and measurement of BCR-ABL, a marker for patients with Chronic Myelogenous Leukemia (CML). This study will compare the performance of the assay to a FDA-cleared assay for the finding of BCR-ABL in blood. |
| Drug/Procedure: | |
| NCT/HDE # | 03421626 |
| Notes: | |
| Start Date: | 10/23/17 |
| Status: | Recruiting |
| Principal Name: | Alan Langerak, MD |
| Contact Name: | Olga Bittner, CCRC |
| Phone: | (208)367-7954 |
| Title: | Specimen Collection for Analytical and/or Clinical Validation Studies of the Xpert® BCR-ABL Ultra Assay on the GeneXpert® Instrument Systems |
| Description: | Cepheid is making a rapid molecular diagnostic test for the detection and measurement of BCR-ABL, a marker for patients with Chronic Myelogenous Leukemia (CML). This study will collect peripheral blood samples from volunteers with CML for assay development, with the purpose of checking the performance traits of the Xpert BCR-ABL Ultra Assay on the GeneXpert instrument systems. |
| Drug/Procedure: | |
| NCT/HDE # | |
| Notes | |
| Start Date: | 9/21/17 |
| Status: | Recruiting |
| Principal Name: | Alan Langerak, MD |
| Contact Name: | Olga Bittner, CCRC |
| Phone: | (208)367-7954 |