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

April 12, 2019 updated by: Cepheid

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

266

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Broward Oncology Associates
    • Idaho
      • Boise, Idaho, United States, 83706
        • St. Alphonsus Regional Medical Center
    • South Carolina
      • Columbia, South Carolina, United States, 29209
        • WJB Dorn VA Medical Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center
    • West Virginia
      • Bridgeport, West Virginia, United States, 26330
        • United Hospital Center
      • Huntington, West Virginia, United States, 25702
        • St. Mary's Medical Center
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline = testing upon enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cepheid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2017

Primary Completion (Actual)

August 20, 2018

Study Completion (Actual)

August 20, 2018

Study Registration Dates

First Submitted

January 30, 2018

First Submitted That Met QC Criteria

January 30, 2018

First Posted (Actual)

February 5, 2018

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 12, 2019

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 231

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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