Genotyping Analysis of Acute Lymphoblastic Leukemia

NCT ID: NCT00961285

Last Updated: 2010-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Acute Lymphoblastic Leukemia Adult

Keywords

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pharmacogenomics genotyping

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)


* No written informed consent
* No DNA samples available
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bologna

OTHER

Sponsor Role lead

Responsible Party

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Institute of Hematology "L. & A. Seragnoli" - University of Bologna

Principal Investigators

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Giovanni Martinelli, prof.

Role: PRINCIPAL_INVESTIGATOR

University of Bologna

Locations

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Institute of Hematology "L. & A. Seragnoli"

Bologna, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giovanni Martinelli, Prof

Role: CONTACT

Phone: +39 051 636

Email: [email protected]

Ilaria Iacobucci, dr.

Role: CONTACT

Phone: +39 051 636

Email: [email protected]

Facility Contacts

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Giovanni Martinelli

Role: primary

Other Identifiers

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GENOTYPING ANALYSIS OF ALL

Identifier Type: -

Identifier Source: org_study_id