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

Leukemia, Myelogenous, Chronic Clinical Trial

Official title:

Clinical Evaluation of the Xpert BCR-ABL Ultra Assay on the GeneXpert Instrument Systems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03421626
• Other study ID #: 231
• Status: Completed
• Start date: November 8, 2017
• Est. completion date: August 20, 2018

Study information

• Verified date: January 2018
• Source: Cepheid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: August 20, 2018
• Est. primary completion date: August 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelogenous, Chronic
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Device:
• Xpert BCR-ABL Ultra
Semi-quantitation of BCR-ABL transcript in patients that have been previously diagnosed with CML

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cepheid

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Method comparison to an on-market molecular diagnostic assay	Comparison of Xpert to an on-market test for the quantitation of BCR-ABL	Baseline = testing upon enrollment