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

NCT ID: NCT04242849

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 354 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-23
• Study Completion Date: 2020-01-16

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

IDH1/2 mutated patients

Patients harboring mutations in IDH1 or IDH2 genes

No interventions assigned to this group

Patients without IDH1/2 mutations

Patients that don´t present any mutation in IDH1/2 genes

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: collaborator

Josep Carreras Leukaemia Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

N/A-NI-AML-PI-007344

Identifier Type: -

Identifier Source: org_study_id