Characterization of Proliferating Compartment in B-Cell Patients and in Healthy Aging Subjects

Completed

• Conditions: Chronic Lymphocytic Leukemia

• Registration Number: NCT01110863
• Lead Sponsor: Northwell Health

Brief Summary

By ingesting a non-radioactive and non-toxic compound "heavy water" for 6 weeks, the DNA of newly developed cells in the body of subjects with B-cell chronic lymphocytic leukemia can be labeled and followed by performing routine blood draws at specified time intervals. By using mass spectrometric analysis we can measure how quickly new B-CLL cells are generated in the bone marrow and how quickly they leave the blood, a measure of cell turnover. This will help us to better understand the unique characteristics of this disease process.

Detailed Description

By ingesting a non-radioactive and non-toxic compound "heavy water" for 6 weeks, the DNA of newly developed cells in the body of subjects with B-cell chronic lymphocytic leukemia (B-CLL) can be labeled and followed by performing routine blood draws at specified time intervals. By using mass spectrometric analysis we can measure how quickly new B-CLL cells are generated in the bone marrow and how quickly they leave the blood, a measure of cell turnover. This will help us to better understand the unique characteristics of this disease process.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2009-12-10
• Study First Submitted QC: 2010-04-23
• Study First Posted: 2010-04-27
• Primary Completion: 2016-02-12
• Study Completion: 2016-02-12
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy,
• Patients who are known to be anemic, with a hemoglobin < 8,
• Patients who are known to be infected with HIV.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characterization of the Proliferating Compartment in B-CLL Patients and in Healthy Aging Subjects	1 year	B-CLL is a dx of accumulation rather than proliferation. Evidence for various forms of clonal evolution suggests that B-CLL clones may be more dynamic than previously assumed. A non-radioactive, stable isotopic labeling method to measure B-CLL cell kinetics in vivo. Subjects drank an aliquot of 2H2O daily for 84 days, and 2H incorporation into the deoxyribose moiety of DNA of their newly divided B-CLL cells, measured by gc/ms, during the labeling period. Birth rates were calculated from the kinetic profiles. Death rates were defined as the difference between calculated birth and growth rates.

Trial Locations

Locations (1)

Feinstein Institute for Medical Research; 🇺🇸 Manhasset, New York, United States