Alternative Splicing and Leukemia Initiating Cells (ASLIC)

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.

Study Overview

• Status: Unknown
• Conditions: Acute Myeloid Leukemia
• Intervention / Treatment: Other: Assessment of splicing variants

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• France
  • Pierre-Bénite, France, 69310
    • Recruiting
    • Service d'hématologie du Centre Hospitalier Lyon Sud
    • Contact: Etienne PAUBELLE, MD, PhD; Phone Number: +33 04 78 86 22 50; Email: Etienne.paubelle@chu-lyon.fr
    • Contact: Erice WATTEL, MD, PhD; Phone Number: +33 04 78 86 22 60; Email: eric.wattel@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with 11q23 acute myeloid leukaemia

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Splicing variants; Sample of acute myeloid leukaemia primary cells	Other: Assessment of splicing variants; This is a biological study with primary samples without any intervention on patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Etienne PAUBELLE, MD, PhD, Service d'hématologie du Centre Hospitalier Lyon Sud

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (Actual): May 17, 2017

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: May 16, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia
• Other Study ID Numbers: 69HCL16_0800

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No