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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01110863

Enrollment

Registered

2010-04-27

Start date

2005-12-31

Completion date

2016-02-12

Last updated

2021-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic Leukemia

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results