Genomic Analysis of Patients With Chronic Lymphocytic Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Universitaire Ziekenhuizen Leuven

ClinicalTrials.gov Identifier:

NCT01346020

First received: April 26, 2011

Last updated: April 29, 2011

Last verified: April 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	April 26, 2011
Last Updated Date	April 29, 2011
Start Date ^ICMJE	April 2010
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: April 29, 2011)	Time to therapy [ Time Frame: baseline to day 1 of therapy ] [ Designated as safety issue: No ] Time from diagnosis to the start of first line therapy
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01346020 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 29, 2011)	Genetic abnormalities detected by karyotyping, FISH or array-analysis [ Time Frame: 13-102 months ] [ Designated as safety issue: No ] 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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Genomic Analysis of Patients With Chronic Lymphocytic Leukemia
Official Title ^ICMJE	Genomic Analysis of Patients With Chronic Lymphocytic Leukemia
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. 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. Clinical data The clinical data were retrospectively collected through collaboration with the referring physicians. 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 Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients with chronic lymphocytic leukemia
Condition ^ICMJE	Chronic Lymphocytic Leukemia
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	CLL
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	53
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: diagnosis of CLL, at least two available stored samples Exclusion Criteria: at least one inclusion criterium not fulfilled
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Belgium

Administrative Information
NCT Number ^ICMJE	NCT01346020
Other Study ID Numbers ^ICMJE	S53270
Has Data Monitoring Committee	Not Provided
Responsible Party	dr. Natalie Put, Department of Human Genetics UZLeuven
Study Sponsor ^ICMJE	Universitaire Ziekenhuizen Leuven
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Universitaire Ziekenhuizen Leuven
Verification Date	April 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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