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

Sponsor
Northwell Health (Other)
Overall Status
Completed
CT.gov ID
NCT01110863
Collaborator
(none)
90
1
122.4
0.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    90 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Characterization of Proliferating Compartment in B-Cell Patients and in Healthy Aging Subjects
    Study Start Date :
    Dec 1, 2005
    Actual Primary Completion Date :
    Feb 12, 2016
    Actual Study Completion Date :
    Feb 12, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Chronic Lymphocytic Leukemia

    Chronic Lymphocytic Leukemia

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Feinstein Institute for Medical Research Manhasset New York United States 11030

    Sponsors and Collaborators

    • Northwell Health

    Investigators

    • Principal Investigator: Nicholas Chiorazzi, MD, Feinstein Institute for Medical Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nicholas Chiorazzi, Investigator, The Feinstein Institute for Medical Research, Northwell Health
    ClinicalTrials.gov Identifier:
    NCT01110863
    Other Study ID Numbers:
    • 05-05-096
    • GAC # 0117
    First Posted:
    Apr 27, 2010
    Last Update Posted:
    Mar 3, 2021
    Last Verified:
    Mar 1, 2021
    Keywords provided by Nicholas Chiorazzi, Investigator, The Feinstein Institute for Medical Research, Northwell Health
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 3, 2021