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The Prospective Collection, Storage and Reporting of Data on Patients Undergoing Hematopoietic Stem Cell Transplantation Utilizing a Standard Preparative Regimen

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ClinicalTrials.gov Identifier: NCT01890486
Recruitment Status : Recruiting
First Posted : July 1, 2013
Last Update Posted : November 17, 2022
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
To provide the IRB approved mechanism for the prospective collection, analysis and reporting of data on patients who are undergoing either an autologous or allogeneic hematopoietic stem cell transplant for a disease in which a research question is not being addressed and for which peer reviewed, published data have demonstrated efficacy for this treatment approach.

Condition or disease
Acute Myelogenous Leukemia Acute Lymphocytic Leukemia Chronic Myelogenous Leukemia Non-Hodgkin's Lymphoma Hodgkin's Disease Multiple Myeloma Germ Cell Neoplasms Myelodysplastic Syndromes Chronic Lymphocytic Leukemia Immunodeficiency Diseases

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: The Prospective Collection, Storage and Reporting of Data on Patients
Actual Study Start Date : May 21, 2001
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2024

Primary Outcome Measures :
  1. Data followup [ Time Frame: 1 year ]
    Gather basic survival and complication data for operational and research databases for ongoing regulatory and futre operational queries

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients who are not on a specific "treatment research protocol" but who are nevertheless receiving "standard of care" dose intensive therapy and either an allogeneic or autologous bone marrow transplant

Inclusion Criteria:

Planned standard of care dose intensive therapy and either an allogeneic or autologous bone marrow transplant

Exclusion Criteria:

participation in any other treatment research protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01890486

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Contact: Dianna Howard, MD dhoward@wakehealth.edu

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United States, North Carolina
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: David Hurd, MD    336-716-2843    dhurd@wakehealth.edu   
Principal Investigator: David Hurd, MD         
Sponsors and Collaborators
Wake Forest University Health Sciences
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Principal Investigator: Dianna Howard, MD Wake Forest University Health Sciences
Additional Information:

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01890486    
Other Study ID Numbers: CCCWFU 95300
First Posted: July 1, 2013    Key Record Dates
Last Update Posted: November 17, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Acute
Hodgkin Disease
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms, Germ Cell and Embryonal
Myelodysplastic Syndromes
Immunologic Deficiency Syndromes
Neoplasms by Histologic Type
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Lymphatic Diseases
Leukemia, B-Cell
Myeloproliferative Disorders