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Genomic Analysis of Patients With Chronic Lymphocytic Leukemia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Active, not recruiting
Information provided by:
Universitaire Ziekenhuizen Leuven Identifier:
First received: April 26, 2011
Last updated: April 29, 2011
Last verified: April 2011

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.

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:

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Time to therapy [ Time Frame: baseline to day 1 of therapy ]
    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 ]
    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


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

Inclusion Criteria:

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

Exclusion Criteria:

  • at least one inclusion criterium not fulfilled
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01346020

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

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

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell processed this record on September 21, 2017