Genomic Analysis of Patients With Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

Genomic Analysis of Patients With Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01346020
• Other study ID #: S53270
• Status: Active, not recruiting
• Phase: N/A
• First received: April 26, 2011
• Last updated: April 29, 2011
• Start date: April 2010

Study information

• Verified date: April 2011
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 53
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• diagnosis of CLL,

• at least two available stored samples

Exclusion Criteria:

• at least one inclusion criterium not fulfilled

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Locations

Country	Name	City	State
Belgium	Department of human genetics, University Hospital Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to therapy	Time from diagnosis to the start of first line therapy	baseline to day 1 of therapy	No
Secondary	Genetic abnormalities detected by karyotyping, FISH or array-analysis	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.	13-102 months	No