Protocol to Obtain Bone Marrow for Research

Completed

• Conditions: Bone Marrow Biopsy
• Interventions: Other: Bone Marrow Aspirate Draw

• Registration Number: NCT00951925
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2005-06
• Study First Submitted: 2009-08-03
• Study First Submitted QC: 2009-08-03
• Study First Posted: 2009-08-04
• Primary Completion: 2016-12
• Study Completion: 2018-12
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No Treatment	Bone Marrow Aspirate Draw	-

Primary Outcome Measures

Name	Time	Method
Regulation of human globin gene expression	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.

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States