Status:
WITHDRAWN
Natural History and Pathophysiology of Gastrointestinal Graft-versus-Host Disease
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Graft-Versus-Host-Disease
Eligibility:
All Genders
18+ years
Brief Summary
This study will determine the best location to biopsy the gastrointestinal (GI) tract for early and accurate diagnosis of GI graft-versus-host-disease (GVHD). (A biopsy is the surgical removal of a sm...
Detailed Description
Graft-versus-host disease (GVHD) affects up to 70% of patients who undergo stem cell transplantation. GVHD is associated with significant morbidity and mortality, and commonly affects the skin, liver,...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- All patients 18 years or older who have undergone or plan to undergo any type of allogeneic bone marrow or peripheral stem cell transplant. (This will be coordinated with all different institutes at NIH to involve patients who participate in NIH affiliated protocols.)
- EXCLUSION CRITERIA:
- Patients who are under the age of 18 years.
- Patients with a platelet count less than 30,000/mm(3).
- Patients with an elevated prothrombin or partial thromboplastin time more than 1.5 times greater than the upper limit of normal or an absolute neutrophil count less than 500/mm(3) of blood or a history of a bleeding diathesis.
- Women who are pregnant, as determined by laboratory evaluation performed according to the referring transplant protocol, or breast feeding.
- Patients who are unable to provide informed consent.
Exclusion
Key Trial Info
Start Date :
July 23 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 4 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00723593
Start Date
July 23 2008
End Date
February 4 2013
Last Update
October 6 2017
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