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

August 3, 2009
February 28, 2014
June 2005
December 2015   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00951925 on ClinicalTrials.gov Archive Site
Not Provided
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Protocol to Obtain Bone Marrow for Research
Protocol to Obtain Bone Marrow for Research

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.

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.

Observational
Observational Model: Cohort
Not Provided
Retention:   Samples With DNA
Description:

5cc of bone marrow aspirate

Non-Probability Sample
  • 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.
Bone Marrow Biopsy
Other: Bone Marrow Aspirate Draw
5cc of Bone Marrow Aspirate will be drawn
No Treatment
Intervention: Other: Bone Marrow Aspirate Draw
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
December 2015   (final data collection date for primary outcome measure)

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.
Both
17 Years and older
Yes
Contact: Research Nurse 800-639-6918 cancer.research.nurse@dartmouth.edu
Contact: Nancy Rollings 603-650-5135 Nancy.J.Rollings@Hitchcock.org
United States
 
NCT00951925
D0529
Yes
Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
Not Provided
Principal Investigator: Christopher H Lowrey, MD Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP