Protocol to Obtain Bone Marrow for Research
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| First Received Date ICMJE | August 3, 2009 | ||||||||
| Last Updated Date | February 13, 2013 | ||||||||
| Start Date ICMJE | June 2005 | ||||||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00951925 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Protocol to Obtain Bone Marrow for Research | ||||||||
| Official Title ICMJE | Protocol to Obtain Bone Marrow for Research | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: 5cc of bone marrow aspirate |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population |
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| Condition ICMJE | Bone Marrow Biopsy | ||||||||
| Intervention ICMJE | Other: Bone Marrow Aspirate Draw
5cc of Bone Marrow Aspirate will be drawn |
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| Study Group/Cohort (s) | No Treatment
Intervention: Other: Bone Marrow Aspirate Draw |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 17 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00951925 | ||||||||
| Other Study ID Numbers ICMJE | D0529 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Dartmouth-Hitchcock Medical Center | ||||||||
| Study Sponsor ICMJE | Dartmouth-Hitchcock Medical Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Dartmouth-Hitchcock Medical Center | ||||||||
| Verification Date | February 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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