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Genomic Analysis of Patients With Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT01346020
Recruitment Status : Unknown
Verified April 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Active, not recruiting
First Posted : May 2, 2011
Last Update Posted : May 2, 2011
Sponsor:
Information provided by:
Universitaire Ziekenhuizen Leuven

Brief Summary:

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 or disease
Chronic Lymphocytic Leukemia

Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Genomic Analysis of Patients With Chronic Lymphocytic Leukemia
Study Start Date : April 2010


Group/Cohort
CLL



Primary Outcome Measures :
  1. Time to therapy [ Time Frame: baseline to day 1 of therapy ]
    Time from diagnosis to the start of first line therapy


Secondary Outcome Measures :
  1. Genetic abnormalities detected by karyotyping, FISH or array-analysis [ Time Frame: 13-102 months ]
    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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01346020


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

Responsible Party: dr. Natalie Put, Department of Human Genetics UZLeuven
ClinicalTrials.gov Identifier: NCT01346020     History of Changes
Other Study ID Numbers: S53270
First Posted: May 2, 2011    Key Record Dates
Last Update Posted: May 2, 2011
Last Verified: April 2011

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