Alternative Splicing and Leukemia Initiating Cells

Acute Myeloid Leukemia Clinical Trial

— ASLIC  

Official title:

Alternative Splicing and Leukemia Initiating Cells

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03156933
• Other study ID #: 69HCL16_0800
• Status: Recruiting
• Phase: N/A
• First received: April 4, 2017
• Last updated: May 16, 2017
• Start date: April 1, 2017
• Est. completion date: April 2018

Study information

• Verified date: April 2017
• Source: Hospices Civils de Lyon
• Contact: Etienne PAUBELLE, MD, PhD
• Phone: 04 78 86 22 50
• Email: Etienne.paubelle[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid, Acute

Intervention

Other:
• Assessment of splicing variants
This is a biological study with primary samples without any intervention on patients.

Locations

Country	Name	City	State
France	Service d'hématologie du Centre Hospitalier Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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