Proteomic Analysis Reveals Innate Immune Activity In Intestinal Transplant Dysfunction

This study has been completed.
Sponsor:
Collaborator:
NIH T32 Human and Molecular Development Training Grant
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01140152
First received: June 7, 2010
Last updated: June 8, 2010
Last verified: February 2010
  Purpose

Many patients with intestinal failure require intestinal transplantation for survival. Currently, the gold standard for diagnosing acute cellular rejection (ACR) is histological examination of endoscopic biopsies, which are taken invasively and lack sensitivity. A non-invasive method of monitoring for ACR is needed.


Condition
Intestinal Transplant
Cellular Rejection

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Proteomic Analysis Reveals Innate Immune Activity In Intestinal Transplant Dysfunction

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Evaluate levels of proteins and cytokines in ostomy effluent during episodes of rejection [ Time Frame: first 8 weeks post transplant ] [ Designated as safety issue: No ]

    Protocol biopsies of the transplanted intestine are obtained during endoscopy and when clinical symptoms indicating abnormal allograft function are present. Biopsies were sent to pathology, where the pathologist determined if there was acute rejection.

    Ostomy effluent taken during times of endoscopy were subjected to MALDI and Luminex technology to look for any proteins or cytokines differentially expressed during rejection.



Biospecimen Retention:   Samples With DNA

Ostomy effluent


Enrollment: 17
Study Start Date: July 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
No rejection
Intestinal transplant recipients with no evidence of biopsy proven rejection
Rejection
Intestinal transplant recipients who had evidence of biopsy proven rejection

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All Intestinal transplant recipients at UCLA, who are up to 8 weeks status-post transplant and are undergoing surveillance endoscopy or who present with elevated stool outputs with concern for acute rejection. Controls will consist of all primary ITx recipients of the same follow-up criteria who are undergoing surveillance biopsies but are at their baseline ostomy outputs.

Criteria

Inclusion Criteria:

  • Intestinal transplant recipient
  • Less than 8 weeks post transplant

Exclusion Criteria:

  • Intestinal transplant recipients more than 8 weeks post transplant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140152

Locations
United States, California
UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
NIH T32 Human and Molecular Development Training Grant
Investigators
Principal Investigator: Anjuli R Kumar, M.D. University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Anjuli Kumar, M.D./Principal Investigator, UCLA
ClinicalTrials.gov Identifier: NCT01140152     History of Changes
Other Study ID Numbers: 08-06-058-02A
Study First Received: June 7, 2010
Last Updated: June 8, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
intestinal transplantation
rejection
proteomics
innate immunity

ClinicalTrials.gov processed this record on August 21, 2014