Trial record 1 of 3 for:    Research Database for Hematopoietic Stem Cell Transplantation
Previous Study | Return to List | Next Study

Protocol For A Research Database For Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Center for International Blood and Marrow Transplant Research
Sponsor:
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier:
NCT01166009
First received: July 16, 2010
Last updated: May 1, 2014
Last verified: May 2014

July 16, 2010
May 1, 2014
July 2002
July 2020   (final data collection date for primary outcome measure)
A Comprehensive Source of Observational Data to assess Stem Cell Transplant [ Time Frame: Anually - on average ] [ Designated as safety issue: No ]

A primary outcome is to have a comprehensive source of stem cell transplant data that can be used to assess topics such as:

  • Recipient Recover time
  • How recovery after transplant can be improved
  • Long term outcomes after transplantation
  • How well donors recover from collection procedure
Same as current
Complete list of historical versions of study NCT01166009 on ClinicalTrials.gov Archive Site
A Comprehensive Source of Data for Marrow Toxic Injuries [ Time Frame: anually- on average ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Protocol For A Research Database For Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries
Protocol For A Research Database For Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries

The primary purpose of the Research Database is to have a comprehensive source of observational data that can be used to study HSC transplantation.

A secondary purpose of the Research Database is to have a comprehensive source of data to study marrow toxic injuries.

Objectives:

To learn more about what makes stem cell transplants work well, such as determining the following:

  • how well recipients recover from their transplant
  • how recovery after a transplant can be improved
  • how access to transplant for different groups of patients can be improved
  • how well donors recover from the collection procedures
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Recipients and Donors that are involved with a stem cell transplantation process.

  • Autologous Stem Cell Transplantation
  • Allogeneic Stem Cell Transplantation
  • Solid Tumors
  • Blood Cancers
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
99999999
Not Provided
July 2020   (final data collection date for primary outcome measure)

Eligibility to Participate in the Research Database

Recipient Eligibility Criteria:

  • Any recipient of an unrelated or related donor or autologous HSC transplant in a CIBMTR center is eligible to participate in the Research Database. This includes adults with and without decision making capacity, and children.

Individual with Marrow Toxic Injury Eligibility Criteria:

  • Any individual who is treated for a marrow toxic injury at a center participating in the NMDP's Radiation Injury Transplant Network (RITN) is eligible to participate in the Research Database. This includes adults with and without decision making capacity, and children. Eligible individuals may have received supportive care only, growth factor support, HSC transplant or other appropriate medical treatment for marrow toxic injury. Treatments applied are at the discretion of the care facility, and are not determined by the NMDP or CIBMTR.

Unrelated Donor Eligibility Criteria:

  • All donors registered on the NMDP Registry who have been requested to donate a product for a recipient are eligible to participate in the Research Database.
  • All maternal cord blood donors are enrolled in the NMDP Cord Blood Bank Investigational New Drug (IND) protocol, and sign an informed consent document specific to that protocol. Data collected as part of the Cord Blood Bank protocol are included in the Research Database.
Both
Not Provided
No
Contact: Marie Matlack 612-627-5811 mmatlack@nmdp.org
United States
 
NCT01166009
NMDP IRB-1999-0021
No
Center for International Blood and Marrow Transplant Research
Center for International Blood and Marrow Transplant Research
Not Provided
Principal Investigator: Douglas Rizzo, M.D.,M.S Center for International Blood and Marrow Transplant Research
Center for International Blood and Marrow Transplant Research
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP