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

NCT01110863 | Completed

• 2 other identifiers: 05-05-096GAC # 0117
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• Characterization of the Proliferating Compartment in B-CLL Patients and in Healthy Aging Subjects

  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.

  1 year

Study Arms (1)

Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chronic Lymphocytic Luekemia

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood cells, Bone Marrow

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicholas Chiorazzi, MD

  Feinstein Institute for Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator, The Feinstein Institute for Medical Research

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: April 27, 2010
• Study Start: December 1, 2005
• Primary Completion: February 12, 2016
• Study Completion: February 12, 2016
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

US (1)