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

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Sponsor:

Information provided by (Responsible Party):

Wake Forest University Health Sciences

Study Description

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

Study Design

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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

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Multiple Myeloma Lymphosarcoma Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Myelodysplastic Syndromes Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Chronic Lymphocytic Leukemia Hodgkin Lymphoma Acute Graft Versus Host Disease Chronic Myeloid Leukemia Chronic Graft Versus Host Disease Chronic Myeloproliferative Disorders

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

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

Contacts

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Contact: Dianna Howard, MD		dhoward@wakehealth.edu

Locations

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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

Investigators

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Principal Investigator:	Dianna Howard, MD	Wake Forest University Health Sciences

More Information

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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Leukemia 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 Neoplasms, Plasma Cell	Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Bone Marrow Diseases Lymphoma Lymphatic Diseases Leukemia, B-Cell Myeloproliferative Disorders

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