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Protocol to Obtain Bone Marrow for Research

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ClinicalTrials.gov Identifier: NCT00951925
Recruitment Status : Active, not recruiting
First Posted : August 4, 2009
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Christopher H. Lowrey, Dartmouth-Hitchcock Medical Center

Brief Summary:
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 or disease Intervention/treatment
Bone Marrow Biopsy Other: Bone Marrow Aspirate Draw

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.

Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Protocol to Obtain Bone Marrow for Research
Study Start Date : June 2005
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Group/Cohort Intervention/treatment
No Treatment Other: Bone Marrow Aspirate Draw
5cc of Bone Marrow Aspirate will be drawn



Primary Outcome Measures :
  1. Regulation of human globin gene expression [ Time Frame: Ongoing ]
    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


Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00951925


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

Responsible Party: Christopher H. Lowrey, Professor of Medicine and of Pharmacology and Toxicology, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00951925     History of Changes
Other Study ID Numbers: D0529
First Posted: August 4, 2009    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

Keywords provided by Christopher H. Lowrey, Dartmouth-Hitchcock Medical Center:
diagnostic bone marrow biopsies
bone marrow harvesting for autologous BMT