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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04242849
Recruitment Status : Completed
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Information provided by (Responsible Party):
Josep Carreras Leukaemia Research Institute

Brief Summary:

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.

Condition or disease
Acute Myeloid Leukemia

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Study Type : Observational
Actual Enrollment : 354 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: IDH1/2 Mutational Analysis in AML Patients: Diagnosis and Follow-up
Actual Study Start Date : May 23, 2016
Actual Primary Completion Date : December 27, 2019
Actual Study Completion Date : January 16, 2020

IDH1/2 mutated patients
Patients harboring mutations in IDH1 or IDH2 genes
Patients without IDH1/2 mutations
Patients that don´t present any mutation in IDH1/2 genes

Primary Outcome Measures :
  1. Presence of IDH1/2 mutation [ Time Frame: 1 day ]
    Detection of mutations in IDH1 and IDH2 genes

Secondary Outcome Measures :
  1. Detection of co-mutations [ Time Frame: 1 day ]
    Screening of aditional mutations in those cases with IDH1/2 mutation

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sampling Method:   Non-Probability Sample
Study Population
Patients >18 years old with de novo acute myeloid leukemia (AML).

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.
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Responsible Party: Josep Carreras Leukaemia Research Institute Identifier: NCT04242849    
Other Study ID Numbers: N/A-NI-AML-PI-007344
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No