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Genotyping Analysis of Acute Lymphoblastic Leukemia

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00961285
Acronym
GALL
Enrollment
1000
Registered
2009-08-18
Start date
2009-03-31
Completion date
2012-12-31
Last updated
2010-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia, Adult

Keywords

pharmacogenomics, genotyping

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

University of Bologna
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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 trialsDecember 2011

Secondary

MeasureTime frame
To study by pharmacogenomic analysis based on SNPs profile, and predict the individual susceptibility (i.e. efficacy and toxicity) to therapeutic treatment and disease developmentDecember 2011
To identify useful biomarkers for disease outcome and disease progressionDecember 2011
To identify useful biomarkers related to drug exposure or to response to potential toxic drugsDecember 2011

Countries

Italy

Contacts

Primary ContactGiovanni Martinelli, Prof
giovanni.martinelli2@unibo.it+39 051 636
Backup ContactIlaria Iacobucci, dr.
ilaria_iacobucci@yahoo.it+39 051 636

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026