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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04242849

Enrollment

354

Registered

2020-01-27

Start date

2016-05-23

Completion date

2020-01-16

Last updated

2025-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Presence of IDH1/2 mutation	1 day	Detection of mutations in IDH1 and IDH2 genes

Secondary

Measure	Time frame	Description
Detection of co-mutations	1 day	Screening of aditional mutations in those cases with IDH1/2 mutation

Outcome results