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Bone Marrow Grafting for Leukemia and Lymphoma

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00186147
Recruitment Status : Enrolling by invitation
First Posted : September 16, 2005
Last Update Posted : August 2, 2021
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Stanford University

Tracking Information
First Submitted Date September 13, 2005
First Posted Date September 16, 2005
Last Update Posted Date August 2, 2021
Study Start Date March 1988
Estimated Primary Completion Date December 2069   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 18, 2014)
Identify and characterize proteins and genes that may contribute to the development and progression of cancer. [ Time Frame: blood sample is collected prior transplant, periodically during the first three months and then indefinately at follow up ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bone Marrow Grafting for Leukemia and Lymphoma
Official Title Bone Marrow Grafting for Leukemia and Lymphoma
Brief Summary The purpose of this study is to obtain tissue samples for ongoing studies regarding transplant outcomes and complications.
Detailed Description The purpose of this study is to acquire critical tissue and biological samples that can be evaluated to elucidate underlying mechanisms of disease control, transplant related complications and overall outcomes
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Tissue samples will be obtained from subjects undergoing transplantation or donors providing the graft.
Sampling Method Non-Probability Sample
Study Population All hematopoietic cell transplant recipients and donors who agree to participate
Condition
  • Leukemia
  • Lymphoma
  • Hematologic Diseases
Intervention Procedure: collection and storage of tissue samples for research
Tissue samples include blood draws for the donor and recipient. A bone marrow sample may be obtained from the recipient. If the recipient undergoes a tissue biopsy for clinical reasons, a small fraction may be removed for research purposes. A small fraction of the donor graft may be removed at the time of collection for research.
Study Groups/Cohorts Graft recipients and donors
Intervention: Procedure: collection and storage of tissue samples for research
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 Enrolling by invitation
Estimated Enrollment
 (submitted: December 4, 2007)
9999
Original Enrollment Not Provided
Estimated Study Completion Date December 2069
Estimated Primary Completion Date December 2069   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:- All hematopoietic cell transplant recipients and donors who agree to participate

Exclusion Criteria:- Subject does not agree to participate

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00186147
Other Study ID Numbers IRB-08903
BMT19 ( Other Identifier: OnCore Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Stanford University
Study Sponsor Stanford University
Collaborators
  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)
Investigators
Principal Investigator: David Miklos Stanford University
Principal Investigator: Robert S Negrin Stanford University
PRS Account Stanford University
Verification Date July 2021