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

Completed

• Conditions: Leukemia, Myelogenous, Chronic
• Interventions: Device: Xpert BCR-ABL Ultra

• Registration Number: NCT03421626
• Lead Sponsor: Cepheid

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-08
• Status Verified: 2018-01
• Study First Submitted: 2018-01-30
• Study First Submitted QC: 2018-01-30
• Study First Posted: 2018-02-05
• Primary Completion: 2018-08-20
• Study Completion: 2018-08-20
• Last Update Submitted: 2019-04-12
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary Enrollment	Xpert BCR-ABL Ultra	Initial enrollment of patients with history of CML

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

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

Marshfield Clinic; 🇺🇸 Marshfield, Wisconsin, United States

Broward Oncology Associates; 🇺🇸 Fort Lauderdale, Florida, United States

United Hospital Center; 🇺🇸 Bridgeport, West Virginia, United States

St. Mary's Medical Center; 🇺🇸 Huntington, West Virginia, United States