This trial is active, not recruiting.

Condition chronic lymphocytic leukemia
Sponsor Universitaire Ziekenhuizen Leuven
Start date April 2010
Trial size 53 participants
Trial identifier NCT01346020, S53270


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective

Primary Outcomes

Time to therapy
time frame: baseline to day 1 of therapy

Secondary Outcomes

Genetic abnormalities detected by karyotyping, FISH or array-analysis
time frame: 13-102 months

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - diagnosis of CLL, - at least two available stored samples Exclusion Criteria: - at least one inclusion criterium not fulfilled

Additional Information

Official title Genomic Analysis of Patients With Chronic Lymphocytic Leukemia
Trial information was received from ClinicalTrials.gov and was last updated in April 2011.
Information provided to ClinicalTrials.gov by Universitaire Ziekenhuizen Leuven.