NCT03156933

Brief Summary

Aberrant RNA splicing and mutations in spliceosome complex in acute myeloid leukaemia (AML) are frequent. It have been shown that some splicing variants had a prognostic value in AML. AML are characterized by their propensity to relapse because of the persistence of leukaemia initiating cells (LICs). The aim of this study is to determine the splice variants on AML initiator cells and define a splicing pattern.

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 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

April 1, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

May 17, 2017

Status Verified

April 1, 2017

Enrollment Period

11 months

First QC Date

April 4, 2017

Last Update Submit

May 16, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Polymerase chain reaction

    Transcriptome analysis to determine the splicing variants on acute myeloid leukaemia initiator cells. The analysis will focus on the gene encoding ABCA3 transporter and genes known to be mutated in patients with acute myeloid leukemia (FLT3, NPM1, c-Kit, N et K-RAS). The duration of selection of samples is estimated to be one month.

    1 month

  • Ribonucleic acid sequencing

    Transcriptome analysis to determine the splicing variants on acute myeloid leukaemia initiator cells. The analysis will focus on the gene encoding ABCA3 transporter and genes known to be mutated in patients with acute myeloid leukemia (FLT3, NPM1, c-Kit, N et K-RAS). The duration of selection of samples is estimated to be one month.

    1 month

Study Arms (1)

Splicing variants

Sample of acute myeloid leukaemia primary cells

Other: Assessment of splicing variants

Interventions

This is a biological study with primary samples without any intervention on patients.

Splicing variants

Eligibility Criteria

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

Patients with 11q23 acute myeloid leukaemia

You may qualify if:

  • Age ≥ 18 years-old
  • Patients treated at the south lyon hospital center
  • Patients with a diagnosis of acute myeloid leukemia confirmed in cytology and whose involvement of the 11q23 locus was confirmed by in situ hybridization
  • Patients for whom a sample is available in the cytogenetic laboratory of the south lyon hospital center

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'hématologie du Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

RNA

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Etienne PAUBELLE, MD, PhD

    Service d'hématologie du Centre Hospitalier Lyon Sud

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Etienne PAUBELLE, MD, PhD

CONTACT

Eric WATTEL, MD, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

April 4, 2017

First Posted

May 17, 2017

Study Start

April 1, 2017

Primary Completion

March 1, 2018

Study Completion

April 1, 2018

Last Updated

May 17, 2017

Record last verified: 2017-04

Locations