Protocol to Obtain Bone Marrow for Research

NCT ID: NCT00951925

Last Updated: 2019-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-06-30

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Bone Marrow Biopsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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No Treatment

Bone Marrow Aspirate Draw

Intervention Type OTHER

5cc of Bone Marrow Aspirate will be drawn

Interventions

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Bone Marrow Aspirate Draw

5cc of Bone Marrow Aspirate will be drawn

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Christopher H. Lowrey

Professor of Medicine and of Pharmacology and Toxicology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher H Lowrey, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

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Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

Other Identifiers

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D0529

Identifier Type: -

Identifier Source: org_study_id

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