Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01166009
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01166009
Recruitment Status : Recruiting
First Posted : July 20, 2010
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research

Tracking Information
First Submitted Date July 16, 2010
First Posted Date July 20, 2010
Last Update Posted Date July 24, 2019
Study Start Date July 2002
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 19, 2010)
A Comprehensive Source of Observational Data to assess Stem Cell Transplant [ Time Frame: Anually - on average ]
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01166009 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 19, 2010)
A Comprehensive Source of Data for Marrow Toxic Injuries [ Time Frame: anually- on average ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Protocol For A Research Database For Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries
Official Title Protocol For A Research Database For Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries
Brief Summary

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

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 and cellular therapies work well such as:

  • Determine how well recipients recover from their transplants or cellular therapy;
  • Determine how recovery after a transplant or cellular therapy can be improved;
  • Determine how a donor's or recipient's genetics impact recipient recovery after a transplant or cellular therapy;
  • Determine how access to transplant or cellular therapy for different groups of patients can be improved;
  • Determine how well donors recover from the collection procedures.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Recipients and Donors that are involved with a stem cell transplantation process.
Condition
  • Autologous Stem Cell Transplantation
  • Allogeneic Stem Cell Transplantation
  • Solid Tumors
  • Blood Cancers
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 19, 2010)
99999999
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2025
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Kay Gardner 763 406 3439 kgardner@nmdp.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01166009
Other Study ID Numbers NMDP IRB-1999-0021
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Center for International Blood and Marrow Transplant Research
Study Sponsor Center for International Blood and Marrow Transplant Research
Collaborators Not Provided
Investigators
Principal Investigator: Douglas Rizzo, M.D.,M.S Center for International Blood and Marrow Transplant Research
PRS Account Center for International Blood and Marrow Transplant Research
Verification Date July 2019