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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03421626
Recruitment Status : Completed
First Posted : February 5, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Cepheid

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Leukemia, Myelogenous, Chronic Device: Xpert BCR-ABL Ultra

Study Design
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Study Type : Observational
Actual Enrollment : 266 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Clinical Evaluation of the Xpert BCR-ABL Ultra Assay on the GeneXpert Instrument Systems
Actual Study Start Date : November 8, 2017
Actual Primary Completion Date : August 20, 2018
Actual Study Completion Date : August 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Groups and Cohorts
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Group/Cohort Intervention/treatment
Primary Enrollment
Initial enrollment of patients with history of CML
 Device: Xpert BCR-ABL Ultra
Semi-quantitation of BCR-ABL transcript in patients that have been previously diagnosed with CML


Outcome Measures
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Primary Outcome Measures :
  1. Method comparison to an on-market molecular diagnostic assay [ Time Frame: Baseline = testing upon enrollment ]
    Comparison of Xpert to an on-market test for the quantitation of BCR-ABL


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Males and females at least 18 years of age who were previously diagnosed with CML from primary care clinics.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421626


Locations
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United States, Florida
Broward Oncology Associates
Fort Lauderdale, Florida, United States, 33308
United States, Idaho
St. Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, South Carolina
WJB Dorn VA Medical Center
Columbia, South Carolina, United States, 29209
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
United States, West Virginia
United Hospital Center
Bridgeport, West Virginia, United States, 26330
St. Mary's Medical Center
Huntington, West Virginia, United States, 25702
United States, Wisconsin
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Cepheid
More Information
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Responsible Party: Cepheid
ClinicalTrials.gov Identifier: NCT03421626    
Other Study ID Numbers: 231
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
 Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases