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Natural History and Pathophysiology of Gastrointestinal Graft-versus-Host Disease

NCT00723593 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2017-10-06

No results posted yet for this study

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 small piece of tissue for examination under the microscope.) GVHD is a life-threatening complication of stem cell transplantation in which the donor s immune cells destroy the patient s healthy tissues. It most commonly affects the skin, liver and GI tract. This study will establish where to best biopsy tissue from the GI tract and study the tissue to try to explore how GI GVD occurs and how it may be possible to better diagnose and treat it.

Patients 18 years of age and older who have undergone or are who will undergo stem cell transplantation and who are at high risk for developing GI GVHD may be eligible for this study. Participants may enter the study before the transplant procedure or later if they develop GVHD symptoms.

Participants undergo the following tests and procedures:

I. Before starting conditioning chemotherapy or radiation therapy for the transplantation

* Medical history and physical examination
* Sigmoidoscopy (endoscopy of the lower part of the large intestine) and biopsies
* Blood draw
* Stool sample collection

II. Two to 3 weeks after conditioning regimen

* Sigmoidoscopy with biopsies
* Blood draw
* Stool sample collection

III. 30, 45, 60 and 90 days after transplantation

-Blood draw

IV. After completing the tests in part II and at the appearance of GI symptoms suspected to be due to GVHD

* Updated medical history and physical examination
* Esophagogastroduodenoscopy (endoscopy of the esophagus, stomach and upper small intestine)
* Colonoscopy (endoscopy of the entire part of the large intestine) with biopsies
* Blood draw
* Stool collection

V. Two weeks after starting therapy in patients diagnosed with GVHD

* Sigmoidoscopy with biopsies
* Blood draw
* Stool sample collection
* PET/CT scan in selected patients (nuclear medicine and x-ray imaging of the GI tract

Conditions

  • Graft-Versus-Host-Disease

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Stephen A Wank, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-23
Completion
2013-02-04

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00723593 on ClinicalTrials.gov