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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

266 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-08

Study Completion Date

2018-08-20

Brief Summary

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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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Detailed Description

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Conditions

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Leukemia, Myelogenous, Chronic

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Primary Enrollment

Initial enrollment of patients with history of CML

Xpert BCR-ABL Ultra

Intervention Type DEVICE

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

Interventions

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Xpert BCR-ABL Ultra

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No