B-type Chronic Lymphocytic Leukemia (B-CLL) Subgroups: Maturation Stage and Gene Expression

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01030913
First received: December 10, 2009
Last updated: February 5, 2013
Last verified: February 2013

December 10, 2009
February 5, 2013
December 1999
January 2015   (final data collection date for primary outcome measure)
differentiating B-CLL cells by the presence or absence of mutations in antibody genes and/or by the percentage of cells expressing CD38 and the differnce in clinical disease course and outcome for each group [ Time Frame: follow through the clinical disease course for each group ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01030913 on ClinicalTrials.gov Archive Site
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B-type Chronic Lymphocytic Leukemia (B-CLL) Subgroups: Maturation Stage and Gene Expression
B-CLL Subgroups: Maturation Stage and Gene Expression

B type chronic lymphocytic leukemia (B-CLL) is the most prevalent leukemia in the western world. It is a disease that occurs primarily in aging individuals and occurs more frequently in males than females. Although B-CLL was considered a homogeneous condition, recent studies by our laboratory and others suggest that B-CLL cases can be divided into two subgroups.

These sub-groups can be identified by either the presence or the absence of mutations in antibody genes and/or by the percentage of B-CLL cells expressing a particular protein called CD38. These two sub-groups (unmutated antibody genes high percent CD38 and mutated antibody genes low percentage CD38) follow strikingly clinically different courses. For example, the unmutated/CD38+ group experiences a much more aggressive disease and these patients almost invariably die much sooner than the cases in the other group. In addition, the patients in the mutated CD38+ group require much more chemotherapy than mutatedlCD38-. Finally, surprisingly there is a much higher representation of males in the poor outcome unmutated CD38 group than in the better outcome group. The reasons for these differences in clinical outcome and gender bias are unknown.

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Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Retention:   Samples With DNA
Description:

Blood Cells, Bone Marrow

Non-Probability Sample

Chronic Lymphocytic Leukemia Community Sample

Chronic Lymphocytic Leukemia
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Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1248
January 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of age,
  • Patients must be able to contribute the required amount of blood without compromising their well being,
  • Participants must be willing to be contacted again in the future for additional blood drawing.

Exclusion Criteria:

  • Patients who are known to be anemic, with a hemoglobin < 8,
  • Patients who are known to be infected with HIV.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01030913
04-057
No
North Shore Long Island Jewish Health System
North Shore Long Island Jewish Health System
Not Provided
Principal Investigator: Nicholas Chiorazzi, MD North Shore-LIJ Health System
North Shore Long Island Jewish Health System
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP