Clinical Evaluation of a Test for Monitoring Patients Diagnosed With Chronic Myeloid Leukemia (CML)

Completed

Conditions studied: Leukemia, Myelogenous, Chronic

In brief

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.

Key facts

Study ID

NCT03421626

Run by

Cepheid

People needed

266

Starts

2017-11-08

Expected to finish

2018-08-20

Last updated by the study team

2019-04-16

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Broward Oncology Associates — Fort Lauderdale, Florida, United States
• St. Alphonsus Regional Medical Center — Boise, Idaho, United States
• WJB Dorn VA Medical Center — Columbia, South Carolina, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
• United Hospital Center — Bridgeport, West Virginia, United States
• St. Mary's Medical Center — Huntington, West Virginia, United States
• Marshfield Clinic — Marshfield, Wisconsin, United States

Full record on ClinicalTrials.gov

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