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

NCT00723593 | Withdrawn

• 2 other identifiers: 08018708-DK-0187
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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

Keywords

Graft-Versus-Host Disease; Gastrointestinal; Apoptotic Assay; Serum Proteomic Pattern Analysis; Mucosal Biopsy; Graft Versus Host Disease; GVHD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Related Publications (3)

• Cahn JY, Klein JP, Lee SJ, Milpied N, Blaise D, Antin JH, Leblond V, Ifrah N, Jouet JP, Loberiza F, Ringden O, Barrett AJ, Horowitz MM, Socie G; Societe Francaise de Greffe de Moelle et Therapie Cellulaire; Dana Farber Cancer Institute; International Bone Marrow Transplant Registry. Prospective evaluation of 2 acute graft-versus-host (GVHD) grading systems: a joint Societe Francaise de Greffe de Moelle et Therapie Cellulaire (SFGM-TC), Dana Farber Cancer Institute (DFCI), and International Bone Marrow Transplant Registry (IBMTR) prospective study. Blood. 2005 Aug 15;106(4):1495-500. doi: 10.1182/blood-2004-11-4557. Epub 2005 May 5.

  PMID: 15878974 BACKGROUND

• Filipovich AH, Weisdorf D, Pavletic S, Socie G, Wingard JR, Lee SJ, Martin P, Chien J, Przepiorka D, Couriel D, Cowen EW, Dinndorf P, Farrell A, Hartzman R, Henslee-Downey J, Jacobsohn D, McDonald G, Mittleman B, Rizzo JD, Robinson M, Schubert M, Schultz K, Shulman H, Turner M, Vogelsang G, Flowers ME. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005 Dec;11(12):945-56. doi: 10.1016/j.bbmt.2005.09.004.

  PMID: 16338616 BACKGROUND

• Martin PJ, McDonald GB, Sanders JE, Anasetti C, Appelbaum FR, Deeg HJ, Nash RA, Petersdorf EW, Hansen JA, Storb R. Increasingly frequent diagnosis of acute gastrointestinal graft-versus-host disease after allogeneic hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2004 May;10(5):320-7. doi: 10.1016/j.bbmt.2003.12.304.

  PMID: 15111931 BACKGROUND

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Stephen A Wank, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 28, 2008
• Study Start: July 23, 2008
• Study Completion: February 4, 2013
• Last Updated: October 6, 2017

Record last verified: 2013-02-04