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Genomic Analysis of Patients With Chronic Lymphocytic Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01346020
First received: April 26, 2011
Last updated: April 29, 2011
Last verified: April 2011
History of Changes
  Purpose

This study aims to characterize clonal evolution in chronic lymphocytic leukemia (CLL) using different approaches and to identify a possible association with disease progression, i.e. therapy initiation.

  1. Samples This monocentric study is carried out using representative bioarchived leukemic samples with a diagnosis of CLL, either at diagnosis or at evolution. These bioarchived samples were collected locally at our center during years of diagnostic activity, and were accurately pathologically, cytogenetically and molecularly characterized.
  2. Clinical data The clinical data were retrospectively collected through collaboration with the referring physicians.
  3. Methods Samples will be investigated by means of (1) conventional cytogenetics, (2) fluorescence in situ hybridization (FISH) and (3) SNP-arrays. After analysis of the array data sets, significant results will be validated and in addition, results will be correlated with clinical data.

Condition
Chronic Lymphocytic Leukemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Genomic Analysis of Patients With Chronic Lymphocytic Leukemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Time to therapy [ Time Frame: baseline to day 1 of therapy ] [ Designated as safety issue: No ]
    Time from diagnosis to the start of first line therapy


Secondary Outcome Measures:
  • Genetic abnormalities detected by karyotyping, FISH or array-analysis [ Time Frame: 13-102 months ] [ Designated as safety issue: No ]
    Detection of any type of genetic abnormality or pattern of abnormalities present at diagnosis or at time of disease progression (e.g. median 41 months after diagnosis, range 13-102 months) by means of karyotyping, fluorescent in situ hybridization or array-analysis.


Enrollment: 53
Study Start Date: April 2010

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with chronic lymphocytic leukemia

Criteria

Inclusion Criteria:

  • diagnosis of CLL,
  • at least two available stored samples

Exclusion Criteria:

  • at least one inclusion criterium not fulfilled
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346020

Locations
Belgium
Department of human genetics, University Hospital Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: dr. Natalie Put, Department of Human Genetics UZLeuven
ClinicalTrials.gov Identifier: NCT01346020     History of Changes
Other Study ID Numbers: S53270
Study First Received: April 26, 2011
Last Updated: April 29, 2011
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
 Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013