ClinicalTrials.gg
Status unknownNCT00961285GALLUpdated Nov 30, 2010

Genotyping Analysis of Acute Lymphoblastic Leukemia

An observational study in Acute Lymphoblastic Leukemia and Adult, sponsored by University of Bologna. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-11-30.

Sponsored by University of Bologna · Observational

The sponsor has not verified this record recently (last verified Aug 2009), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Lymphoblastic Leukemia
  • Adult

Keywords

  • pharmacogenomics
  • genotyping
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In context

Precursor Cell Lymphoblastic Leukemia-Lymphoma

2,121 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 492 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 120 across 313 observational studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

University of Bologna is the lead sponsor of 158 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

adult ALL patients

Eligibility criteria

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
05

Study design

Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. 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

    Time frame: December 2011

Secondary outcomes

  1. 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

    Time frame: December 2011

  2. To identify useful biomarkers for disease outcome and disease progression

    Time frame: December 2011

  3. To identify useful biomarkers related to drug exposure or to response to potential toxic drugs

    Time frame: December 2011

07

Study locations

1 of 1 sites recruiting
  • Institute of Hematology "L. & A. Seragnoli"
    Bologna, 40138, Italy
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00961285
First posted
Aug 18, 2009
Start date
Mar 2009
Primary completion
Dec 2011 (estimated)
Completion
Dec 2012 (estimated)
Last update
Nov 30, 2010

Study contacts

Giovanni Martinelli, Prof
Contact
giovanni.martinelli2@unibo.it
+39 051 636 ext. 3829
Ilaria Iacobucci, dr.
Contact
ilaria_iacobucci@yahoo.it
+39 051 636 ext. 3791
Giovanni Martinelli, prof.
principal investigator · University of Bologna

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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