Collection of Blood and/or Bone Marrow for Investigation and Characterization of Normal and Abnormal Cell Growth
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01174615 |
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Recruitment Status :
Recruiting
First Posted : August 3, 2010
Last Update Posted : May 12, 2023
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Sponsor:
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Jan Cerny, University of Massachusetts, Worcester
| Tracking Information | |||||||||
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| First Submitted Date | May 24, 2010 | ||||||||
| First Posted Date | August 3, 2010 | ||||||||
| Last Update Posted Date | May 12, 2023 | ||||||||
| Study Start Date | September 2009 | ||||||||
| Estimated Primary Completion Date | December 2099 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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 ] 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 | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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 ] 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 | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Collection of Blood and/or Bone Marrow for Investigation and Characterization of Normal and Abnormal Cell Growth | ||||||||
| Official Title | 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. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Other Time Perspective: Prospective |
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| 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. | ||||||||
| Condition | Leukemia | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | 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 | Recruiting | ||||||||
| Estimated Enrollment |
1000 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 2100 | ||||||||
| Estimated Primary Completion Date | December 2099 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | 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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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT01174615 | ||||||||
| Other Study ID Numbers | UM200901 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||
| IPD Sharing Statement | Not Provided | ||||||||
| Current Responsible Party | Jan Cerny, University of Massachusetts, Worcester | ||||||||
| Original Responsible Party | Jan Cerny, MD, PhD, University of Massachusetts Medical School | ||||||||
| Current Study Sponsor | University of Massachusetts, Worcester | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | University of Massachusetts, Worcester | ||||||||
| Verification Date | May 2023 | ||||||||