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

Sponsor
Cepheid (Industry)
Overall Status
Completed
CT.gov ID
NCT03421626
Collaborator
(none)
266
Enrollment
7
Locations
9.4
Actual Duration (Months)
38
Patients Per Site
4.1
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Device: Xpert BCR-ABL Ultra

Study Design

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 :
Nov 8, 2017
Actual Primary Completion Date :
Aug 20, 2018
Actual Study Completion Date :
Aug 20, 2018

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Method comparison to an on-market molecular diagnostic assay [Baseline = testing upon enrollment]

    Comparison of Xpert to an on-market test for the quantitation of BCR-ABL

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Broward Oncology Associates Fort Lauderdale Florida United States 33308
2 St. Alphonsus Regional Medical Center Boise Idaho United States 83706
3 WJB Dorn VA Medical Center Columbia South Carolina United States 29209
4 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109
5 United Hospital Center Bridgeport West Virginia United States 26330
6 St. Mary's Medical Center Huntington West Virginia United States 25702
7 Marshfield Clinic Marshfield Wisconsin United States 54449

Sponsors and Collaborators

  • Cepheid

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cepheid
ClinicalTrials.gov Identifier:
NCT03421626
Other Study ID Numbers:
  • 231
First Posted:
Feb 5, 2018
Last Update Posted:
Apr 16, 2019
Last Verified:
Jan 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Study Results

No Results Posted as of Apr 16, 2019