Collection of Blood and/or Bone Marrow for Investigation and Characterization of Normal and Abnormal Cell Growth
This study is currently recruiting participants.
Verified February 2013 by University of Massachusetts, Worcester
Sponsor:
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Jan Cerny, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01174615
First received: May 24, 2010
Last updated: February 22, 2013
Last verified: February 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 24, 2010 | ||||||||
| Last Updated Date | February 22, 2013 | ||||||||
| Start Date ICMJE | September 2009 | ||||||||
| Estimated Primary Completion Date | December 2099 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The study is designed to collect blood and bone marrow from patients with various hematological diseases. [ Time Frame: On average, indefinite, or until death of participant ] [ Designated as safety issue: No ] The study is designed to collect blood and bone marrow from patients with various hematological diseases. The samples will be used for various research studies for better understanding of biology of various blood disorders including hematological malignancies. Relevant clinical and laboratory features and subsequent changes will be noted for correlation with these studies. The tissue/cells will be additionally banked and/or used for other investigations in the future. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01174615 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Collection of Blood and/or Bone Marrow for Investigation and Characterization of Normal and Abnormal Cell Growth in Patients With Malignancy or Hematologic Disorders [ Time Frame: On average, indefinite, or until death of participant ] [ Designated as safety issue: No ] Develop a database of subjects who have donated samples for research as well as tissue banking, some of whom may be contacted again for consideration of additional studies in the future. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Collection of Blood and/or Bone Marrow for Investigation and Characterization of Normal and Abnormal Cell Growth | ||||||||
| Official Title ICMJE | Collection of Blood and/or Bone Marrow for Investigation and Characterization of Normal and Abnormal Cell Growth in Patients With Malignancy or Hematologic Disorders | ||||||||
| Brief Summary | The collection of Blood and/or Bone Marrow from patients with blood disorders, blood cell malignancies and associated conditions will serve as a convenient and comprehensive source of tissue to give us further information about the differences between normal blood cells and blood cells of affected individuals. This will be an invaluable asset for understanding the biology of blood disorders. The collected samples will be used by investigators for studies including immunology, molecular biology and genetics to name a few. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Time Perspective: Prospective | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: Tissue/cells from patients' samples. |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients over the age of 18 with blood and/or bone disorders (leukemia, myeloproliferative disorders, lymphoma etc.) with alterations of their blood counts. |
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| Condition ICMJE | Leukemia | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| 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 | 1000 | ||||||||
| Estimated Completion Date | December 2100 | ||||||||
| Estimated Primary Completion Date | December 2099 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Patients who are scheduled to undergo a bone marrow aspirate and/or phlebotomy for other clinical indications will be asked to participate. They will be asked to donate an additional small aliquot of bone marrow and/or blood during the course of their already scheduled bone marrow aspiration or phlebotomy. Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01174615 | ||||||||
| Other Study ID Numbers ICMJE | UM200901 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Jan Cerny, University of Massachusetts, Worcester | ||||||||
| Study Sponsor ICMJE | University of Massachusetts, Worcester | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Massachusetts, Worcester | ||||||||
| 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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