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
Enrollment
1
Location
275.4
Anticipated Duration (Months)
7.3
Patients Per Site Per Month

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.

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

  1. 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

SiteCityStateCountryPostal Code
1Wake Forest Baptist HealthWinston-SalemNorth CarolinaUnited States27157

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

Study Results

No Results Posted as of Nov 26, 2021