NCT03499912

Brief Summary

  1. 1.To assess the incidence of IDH1 and IDH2 mutations in adult AML patients, and to explore their associations with the patients' clinical, cytogenetic, and molecular characteristics as well as with treatment response and outcome.
  2. 2.To delineate the similarities and distinctions among mutations at IDH1-R132, IDH2-R140 and IDH2-R172 in AML, both clinically and molecularly (including cytogenetics, immunophenotyping, mutation co-occurrence patterns).
  3. 3.The results can be references for future selection of targeted therapy (targeting IDH mutant proteins).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

April 20, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

March 22, 2018

Last Update Submit

April 18, 2018

Conditions

Acute Myeloid Leukemia

Keywords

Acute myeloid leukemiaIDH1IDH2Genetic mutationsPrognosis

Outcome Measures

Primary Outcomes (1)

  • Incidence of IDH1 and IDH2 mutation

    Peripheral blood or marrow blood will be obtained from routine practice blood/marrow sampling specimens (no extra venipuncture or bone marrow aspiration would be required) and sent for routine tests such as cytogenetics, immunophenotyping, and gene mutation analyses.

    2017/03/07 - 2019/03/01

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult AML patients (newly diagnosed or relapsed) diagnosed at the National Taiwan University Hospital (NTUH) according to the updated 2016 WHO AML classification criteria.

You may qualify if:

  • Patients ≥20 Years with Diagnosed Acute Myeloid Leukemia
  • Willing to provide voluntary written informed consent before study related procedures

You may not qualify if:

  • Not acute myeloid leukemia patients
  • Patients \<20 Years with Diagnosed Acute Myeloid Leukemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Wen-Chien Chou

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen-Chien Chou

CONTACT

0972651701wchou@ntu.edu.tw

Ming-Kai Chuang

CONTACT

0972652258mingkai@ntuh.gov.tw

Study Design

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

Study Record Dates

First Submitted

March 22, 2018

First Posted

April 17, 2018

Study Start

March 29, 2017

Primary Completion

April 1, 2019

Study Completion

July 1, 2019

Last Updated

April 20, 2018

Record last verified: 2018-03

Locations

TW(1)