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OpenTrials
Completed

NCT Number: NCT04242849

IDH1/2 Mutational Analysis in AML Patients: Diagnosis and Follow-up

In a spanish series of AML patients it is intended to perform, at the moment of diagnosis, pyrosequencing of IDH1 and IDH2 genes. Taking into account the incidence of AML in the area, it is planed to study 100 patients per year.

Among the cases with IDH1/2 mutations, targeted deep sequencing (TDS) of a panel covering coding regions of 40 myeloid related genes will be applied. With TDS, pyrosequencing results will be validated at the same time that prognosis value of co-mutated genes could be studied. Furthermore, with TDS, molecular architecture of IDH1 and IDH2 mutated cases might be better understood.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients >18 years old with de novo acute myeloid leukemia will be included. All patients will be treated according to clinical routine.

Exclusion criteria

  • Patients not following the above criteria.

Treatment and study plan

Primary outcomes

  1. Presence of IDH1/2 mutation

    Time frame: 1 day

    Detection of mutations in IDH1 and IDH2 genes

Secondary outcomes

  1. Detection of co-mutations

    Time frame: 1 day

    Screening of aditional mutations in those cases with IDH1/2 mutation

Sponsors and collaborators

Lead sponsor

Josep Carreras Leukaemia Research Institute

Other

Collaborators

  • Celgene

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jan 27, 2020
Registry last updated
Feb 21, 2025

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

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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.

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