Genotyping Analysis of Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia Clinical Trial

— GALL  

Official title:

High Resolution Genome Wide-Copy Number Profiling and Pharmacogenomic Analysis in Acute Lymphoblastic Leukemia by Single Nucleotide Polymorphism (SNP) Arrays

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00961285
• Other study ID #: GENOTYPING ANALYSIS OF ALL
• Status: Recruiting
• Phase: N/A
• First received: August 17, 2009
• Last updated: November 29, 2010
• Start date: March 2009
• Est. completion date: December 2012

Study information

• Verified date: August 2009
• Source: University of Bologna
• Contact: Giovanni Martinelli, Prof
• Phone: +39 051 636
• Email: giovanni.martinelli2[@]unibo.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Identification of alterations potentially involved in the complex mechanisms of leukemogenesis and at the identification and validation of novel biological factors which may serve as predictors of drug-response and drug-resistance or which may be suitable for targeted therapy.

Description:

The investigators will use several approach to identify common genetic variations: single-nucleotide polymorphisms (SNPs), genomic insertions and deletions, and genetic copy number variations (CNVs), interchromosomal translocations, loss of heterozygosity (LOH), and uniparental disomy (UPD), Epigenetic changes, such as silencing of gene expression via DNA hypermethylation, that can also influence drug effects, and aberrant methylation of CpG islands is a common feature of cancer cells. Over the years, methods of cytogenetic analysis evolved and became part of routine laboratory testing, providing valuable diagnostic and prognostic information in hematologic disorders. The recently developed single nucleotide polymorphism (SNP) arrays offer the ability to define simultaneously the copy number changes and loss of heterozygosity (LOH) events occurring in a tumor, at high resolution and throughout the genome. In addition to information on copy number changes, SNP arrays allow us to investigate the impact of a high number of SNPs on drug response and toxicity This molecular integrated approach will lead to the identification of alterations potentially involved in the complex mechanisms of leukemogenesis and at the identification and validation of novel biological factors which may serve as predictors of drug-response and drug-resistance or which may be suitable for targeted therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Acute Lymphoblastic Leukemia of any subtype OR Lymphoid blast crisis Chronic Myeloid Leukemia

• Age > 18 years

• Available data set of clinical data for review (demographics including ethnicity, stage of disease, concise treatment history, cytogenetic reports, and molecular results if available as routinely performed during diagnosis procedures)

Inclusion Criteria:

• No written informed consent

• No DNA samples available

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Adult
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
Italy	Institute of Hematology "L. & A. Seragnoli"	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide high resolution molecular karyotyping analysis by single nucleotide polymorphism array (SNP 6.0, Affymetrix) of adult patients with diagnosis of acute lymphoblastic leukemia (ALL), newly enrolled in clinical trials		December 2011	No
Secondary	To study by pharmacogenomic analysis based on SNPs profile, and predict the individual susceptibility (i.e. efficacy and toxicity) to therapeutic treatment and disease development		December 2011	No
Secondary	To identify useful biomarkers for disease outcome and disease progression		December 2011	No
Secondary	To identify useful biomarkers related to drug exposure or to response to potential toxic drugs		December 2011	No