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
  Purpose

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

Condition
Autologous Stem Cell Transplantation
Allogeneic Stem Cell Transplantation
Solid Tumors
Blood Cancers

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Protocol For A Research Database For Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries

Further study details as provided by Center for International Blood and Marrow Transplant Research:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • A Comprehensive Source of Data for Marrow Toxic Injuries [ Time Frame: anually- on average ] [ Designated as safety issue: No ]

Estimated Enrollment: 99999999
Study Start Date: July 2002
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166009

Contacts
Contact: Marie Matlack 612-627-5811 mmatlack@nmdp.org

Locations
United States, Minnesota
Center for International Blood and Marrow Transplant Research Recruiting
Minneapolis, Minnesota, United States, 55413
Sponsors and Collaborators
Center for International Blood and Marrow Transplant Research
Investigators
Principal Investigator: Douglas Rizzo, M.D.,M.S Center for International Blood and Marrow Transplant Research
  More Information

No publications provided

Responsible Party: Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier: NCT01166009     History of Changes
Obsolete Identifiers: NCT00923585, NCT01160497
Other Study ID Numbers: NMDP IRB-1999-0021
Study First Received: July 16, 2010
Last Updated: May 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Center for International Blood and Marrow Transplant Research:
Data Collection
CIBMTR
NMDP
Stem Cell Transplantation

Additional relevant MeSH terms:
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases

ClinicalTrials.gov processed this record on October 02, 2014