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

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.

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Key information

Conditions

Leukemia, Myelogenous, Chronic Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Broward Oncology Associates, Fort Lauderdale, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xpert BCR-ABL Ultra

Device

Semi-quantitation of BCR-ABL transcript in patients that have been previously diagnosed with CML

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Cepheid

Industry

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Feb 5, 2018
Registry last updated: Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed