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

NCT03421626 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 266

Last updated 2019-04-16

No results posted yet for this study

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.

Conditions

  • Leukemia, Myelogenous, Chronic

Interventions

DEVICE

Xpert BCR-ABL Ultra

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

Sponsors & Collaborators

  • Cepheid

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-08
Primary Completion
2018-08-20
Completion
2018-08-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03421626 on ClinicalTrials.gov