Protocol to Obtain Bone Marrow for Research

This study is currently recruiting participants.
Verified February 2014 by Dartmouth-Hitchcock Medical Center
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00951925
First received: August 3, 2009
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

Potential donors who are undergoing bone marrow biopsy or bone marrow donation as part of clinical care will be asked by the principal investigator (PI) if they might be interested in donating marrow for this research project. If they are interested, the PI will meet with the prospective donor to review the information contained in the informed consent document and to answer any questions the potential subject may have. Bone marrow aspirates of approximately 5cc will be obtained from the posterior iliac crest of subjects using standard techniques.


Condition Intervention
Bone Marrow Biopsy
Other: Bone Marrow Aspirate Draw

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Protocol to Obtain Bone Marrow for Research

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Regulation of human globin gene expression [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
    The purpose of this study is to determine the mechanisms that regulate human globin gene expression by analyzing the function of cell signaling pathways and the expression of other related genes and their protein products in the bone marrow cells of people without blood diseases.


Biospecimen Retention:   Samples With DNA

5cc of bone marrow aspirate


Estimated Enrollment: 100
Study Start Date: June 2005
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No Treatment Other: Bone Marrow Aspirate Draw
5cc of Bone Marrow Aspirate will be drawn

Detailed Description:

The purpose of this study is to determine the mechanisms that regulate human globin gene expression by analyzing the function of cell signaling pathways and the expression of other related genes and their protein products in the bone marrow cells of people without blood diseases. This includes the effects of drugs and other in vitro manipulations of the cells once they are removed from donors. These assays will include, but are not limited to, determinations of DNA methylation status, histone acetylation profiles, DNAse sensitivity, transcription factor binding to DNA, levels of various proteins, messenger RNAs and miRNAs in the cells of the marrow samples. By understanding how this process occurs in people without blood diseases, we hope to to design future treatments for people with diseases such as sickle cell disease and B-thalassemia.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • Patients undergoing diagnostic bone marrow biopsies at the Norris Cotton Cancer Center of Dartmouth Hitchcock Medical Center (DHMC).
  • Patients undergoing bone marrow harvesting for autologous bone marrow transplantation.
Criteria

Inclusion Criteria:

  • Patients undergoing diagnostic bone marrow biopsies at the Norris Cotton Cancer Center of DHMC.
  • Patients undergoing bone marrow harvesting for autologous bone marrow transplantation.
  • Normal donors undergoing bone marrow harvesting for autologous bone marrow transplantation.
  • Normal persons over the age of 17 who volunteer to undergo bone marrow aspiration.

Exclusion Criteria:

  • Normal volunteers with known allergies to lidocaine (or similar analgesics)or betadine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00951925

Contacts
Contact: Research Nurse 800-639-6918 cancer.research.nurse@dartmouth.edu
Contact: Nancy Rollings 603-650-5135 Nancy.J.Rollings@Hitchcock.org

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Principal Investigator: Christopher H Lowrey, MD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Christopher H Lowrey, MD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00951925     History of Changes
Other Study ID Numbers: D0529
Study First Received: August 3, 2009
Last Updated: February 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
Any patient undergoing diagnostic bone marrow biopsies
Any patient undergoing bone marrow harvesting for autologous bone marrow transplantation.

ClinicalTrials.gov processed this record on April 16, 2014