Genomic Analysis of Patients With Chronic Lymphocytic Leukemia

Active, not recruiting

• Conditions: Chronic Lymphocytic Leukemia

• Registration Number: NCT01346020
• Lead Sponsor: Universitaire Ziekenhuizen KU 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2011-04-26
• Study First Submitted QC: 2011-04-29
• Study First Posted: 2011-05-02
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

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

Exclusion Criteria

• at least one inclusion criterium not fulfilled

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to therapy	baseline to day 1 of therapy	Time from diagnosis to the start of first line therapy

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of human genetics, University Hospital Leuven; 🇧🇪 Leuven, Belgium