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

Plain-language summary

This study evaluated the setup of a centralized, standardized rapid molecular-diagnosis platform using next-generation sequencing (NGS) in patients diagnosed with acute myeloid leukemia. It enrolled adults aged 18 and older with acute myeloid leukemia (excluding acute promyelocytic leukemia) by WHO criteria. The trial was a non-phase study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

PETHEMA Foundation

Intervention

NGS techniques

Start date

10/6/2017

Estimated completion

10/15/2019

Countries

Spain

Related genes

Locations

• Córdoba, Spain
• Las Palmas de Gran Canaria, Spain
• Madrid, Spain
• Pamplona, Spain
• Salamanca, Spain
• Seville, Spain
• Valencia, Spain

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* 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 Criteria:

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