NCT04242849CompletedNot Applicable
IDH1/2 Mutational Analysis in AML Patients: Diagnosis and Follow-up
Josep Carreras Leukaemia Research Institute0 sites354 target enrollmentStarted: May 23, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 354
- Primary Endpoint
- Presence of IDH1/2 mutation
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Presence of IDH1/2 mutation
Time Frame: 1 day
Detection of mutations in IDH1 and IDH2 genes
Secondary Outcomes
- Detection of co-mutations(1 day)
Investigators
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