Protocol to Obtain Bone Marrow for Research

March 5, 2019 updated by: Christopher H. Lowrey, Dartmouth-Hitchcock Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Investigators

  • Principal Investigator: Christopher H Lowrey, MD, Dartmouth-Hitchcock Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

August 3, 2009

First Submitted That Met QC Criteria

August 3, 2009

First Posted (Estimate)

August 4, 2009

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D0529

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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