Status:

COMPLETED

Diagnostic Platform to Perform Centralized and Standardized Rapid Molecular Diagnosis by Next Generation Sequencing (NGS) in Patients Diagnosed With Acute Myeloid Leukemia.

Lead Sponsor:

PETHEMA Foundation

Conditions:

Acute Myeloid Leukemia

Eligibility:

All Genders

18+ years

Brief Summary

NGS studies will be done in stem cell leukemic population. The analysis of the samples to the diagnosis will be carried out using the 26 consensus genes: ASXL1 had, CBL, CEBPA, DNMT3A, EZH2, FLT3, GAT...

Detailed Description

All patients diagnosed with AML (new diagnosis or relapsed/refractory disease) can be included. This project aims to establish a platform for comprehensive diagnostic and research platform in the con...

Eligibility Criteria

Inclusion

  • All adult patients (≥18 years) with AML (excluding APL) according to the WHO criteria (2008), regardless of the treatment administered by their treating physician.
  • Patient has to sign the informed consent form, allowing for sampling, analyses and reporting of the mutational results.
  • AML at diagnosis and at relapse or refractoriness.

Exclusion

  • Genetic diagnosis of acute promyelocytic leukemia
  • No Informed Consent Form

Key Trial Info

Start Date :

October 6 2017

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

October 15 2019

Estimated Enrollment :

900 Patients enrolled

Trial Details

Trial ID

NCT03311815

Start Date

October 6 2017

End Date

October 15 2019

Last Update

February 16 2021

Active Locations (7)

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Page 1 of 2 (7 locations)

1

Hospital Reina Sofía

Córdoba, Spain

2

Hospital Dr. Negrín

Las Palmas de Gran Canaria, Spain

3

Hospital 12 de Octubre

Madrid, Spain

4

Clínica Universidad de Navarra

Pamplona, Spain