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Genomic Analysis of Patients With Chronic Lymphocytic Leukemia

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Unknown status
CT.gov ID
NCT01346020
Collaborator
(none)
53
Enrollment
1
Location

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Apr 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    CLL

    Outcome Measures

    Primary Outcome Measures

    1. Time to therapy [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • diagnosis of CLL,

    • at least two available stored samples

    Exclusion Criteria:
    • at least one inclusion criterium not fulfilled

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of human genetics, University Hospital Leuven Leuven Belgium 3000

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen Leuven

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01346020
    Other Study ID Numbers:
    • S53270
    First Posted:
    May 2, 2011
    Last Update Posted:
    May 2, 2011
    Last Verified:
    Apr 1, 2011
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Lymphoid
    Leukemia, Lymphocytic, Chronic, B-Cell

    Study Results

    No Results Posted as of May 2, 2011