NCT04242849

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
354

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2019

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
Last Updated

February 21, 2025

Status Verified

January 1, 2020

Enrollment Period

3.6 years

First QC Date

January 16, 2020

Last Update Submit

February 19, 2025

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • Presence of IDH1/2 mutation

    Detection of mutations in IDH1 and IDH2 genes

    1 day

Secondary Outcomes (1)

  • Detection of co-mutations

    1 day

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients \>18 years old with de novo acute myeloid leukemia (AML).

You may qualify if:

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

You may not qualify if:

  • Patients not following the above criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Samples of bone marrow and peripheral blood of patients with AML

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2020

First Posted

January 27, 2020

Study Start

May 23, 2016

Primary Completion

December 27, 2019

Study Completion

January 16, 2020

Last Updated

February 21, 2025

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share