Clinical Evaluation of a Test for Monitoring Patients Diagnosed With Chronic Myeloid Leukemia (CML)
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 2/7/2018 |
| Start Date: | November 8, 2017 |
| End Date: | April 27, 2018 |
| Contact: | Sarah Brown |
| Email: | sarah.brown@cepheid.com |
| Phone: | 847-228-3298 |
Clinical Evaluation of the Xpert BCR-ABL Ultra Assay on the GeneXpert Instrument Systems
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.
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.
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
We found this trial at
7
sites
Marshfield, Wisconsin 54449
Principal Investigator: Kajal Sitwala, MD
Phone: 715-221-6278
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6405 N Federal Hwy # 300
Fort Lauderdale, Florida 33308
Fort Lauderdale, Florida 33308
Principal Investigator: Luis Barreras, MD
Phone: 954-771-0692
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1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000
Principal Investigator: Vivian Oehler, MD
Phone: 206-667-7252
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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Boise, Idaho 83702
Principal Investigator: Alan Langerak, MD
Phone: 208-367-7954
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Bridgeport, West Virginia 26330
Principal Investigator: Salman Osman, MD
Phone: 304-293-6251
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Columbia, South Carolina 29209
Principal Investigator: Mohammed Wallam, MD
Phone: 803-776-4000
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Huntington, West Virginia 25702
Principal Investigator: Arvinder Bir, MD
Phone: 304-293-6251
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