The Prospective Collection, Storage and Reporting of Data on Patients Undergoing Hematopoietic Stem Cell Transplantation Utilizing a Standard Preparative Regimen
Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT01890486
Collaborator
(none)
2,000
1
275.4
7.3
Study Details
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 | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
2000 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
The Prospective Collection, Storage and Reporting of Data on Patients
Actual Study Start Date
:
May 21, 2001
Anticipated Primary Completion Date
:
May 1, 2023
Anticipated Study Completion Date
:
May 1, 2024
Outcome Measures
Primary Outcome Measures
- Data followup [1 year]
Gather basic survival and complication data for operational and research databases for ongoing regulatory and futre operational queries
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wake Forest Baptist Health | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Dianna Howard, MD, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT01890486
Other Study ID Numbers:
- CCCWFU 95300
First Posted:
Jul 1, 2013
Last Update Posted:
Nov 26, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: