Biomarkers in Transplant Recipients

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by University of Pittsburgh
Information provided by (Responsible Party):
Rakesh Sindhi, University of Pittsburgh Identifier:
First received: June 29, 2010
Last updated: May 11, 2016
Last verified: May 2016

June 29, 2010
May 11, 2016
March 2005
March 2020   (final data collection date for primary outcome measure)
Rejection [ Time Frame: 90 day post transplantation (clinical severity) ] [ Designated as safety issue: No ]
Biopsy-proven acute cellular rejection
Rejection or Graft vs. Host Disease [ Time Frame: 90 day post transplantation (clinical severity) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01163578 on Archive Site
Thresholds of immunosuppression [ Time Frame: Yearly post transplantation ] [ Designated as safety issue: No ]
Blood levels and doses of the various immunosuppressants at one year. For example, Tacrolimus is measured as nanograms/ml in whole blood, Mycophenolate mofetil is measured in doses of mg/day, or as blood levels in micrograms/ml, steroids doses are measured in mg/day, Sirolimus is measured in doses of mg/day, or as blood levels in nanograms/ml in whole blood.
  • Thresholds of immunosuppression associated with opportunistic infections and malignancies due to immunosuppression, and blood levels and doses of the various immunosuppressants [ Time Frame: Yearly post transplantation ] [ Designated as safety issue: No ]
  • Various types of diseases leading to organ and bone marrow transplantation [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Ischemia-reperfusion injury associated with organ preservation prior to transplantation [ Time Frame: Within 8 hours of engraftment ] [ Designated as safety issue: No ]
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Biomarkers in Transplant Recipients
Study of Biomarkers in Solid Organ and Bone Marrow Transplant Recipients to Better Treat Rejection
The objective of this study is to evaluate whether certain proteins, expressed in biological tissues can indict a better understanding of the effect of drugs that are used to treat rejection, and of processes leading to rejection and rejection-free outcomes.

All transplant recipients receive periodic monitoring of drug levels and laboratory tests to assess adequacy of immunosuppression and allograft function. These are performed when the recipient is admitted to the hospital after transplantation or for a complication such as acute rejection or toxicity, or when the recipient is an outpatient.

  1. Blood samples: Participants will be asked to provide research blood specimens annually for an indefinite period of time. This will allow longitudinal assessment of the stability of biomarker expression as a reflection of clinical drug concentrations in repeated measurements.
  2. Saliva collection: Up to 5 ml of the subject's saliva will be collected no more than four times, if the previous sample does not provide adequate information. Samples will be collected in self-collection container at the time of consent or as early as possible after consents are obtained, and will be stored at room temperature in the Pediatric Transplantation Laboratory, 3344 Forbes Ave. In recipients where both are available, the genotyping results as DNA from saliva will be compared between paired blood samples. Henceforth, saliva collection will only be offered to participants who cannot donate blood specimens for genotyping. Salivary sampling is considered an acceptable alternative standard for whole blood genotyping. A saliva sample will be collected only if the patient or the patient's parent or guardian prefers this option over blood sampling.
  3. Collection of urine, feces, and bile: five mls of any body fluid will be collected in sterile urine cups for application of proteomics technologies. Collections may be repeated up to four times, if the first specimen provides suboptimal information.
  4. Collection of remaining allograft standard of care biopsy specimens, and tissue from explants: Any piece of allograft biopsy deemed residual by the pathologist will be subjected to gene array testing. This will occur when participant is scheduled for their standard of care biopsy, or while in surgery. Genetic material extracted from the smallest tissue can be amplified using several approaches.
  5. Measurements: Biomarker expression will be evaluated after mitogen and antigen stimulation of peripheral blood mononuclear cells. (1-3). Briefly, peripheral blood mononuclear cells (PBMC) are extracted from whole blood by Ficoll gradient separation, Thereafter, either mitogens such as phytohemaglutinin, pokeweed mitogen, or phorbol-myristic acid-ionomycin, or viral and major histocompatibility complex (MHC) peptide antigens, or intact alloantigenic cells will be used to stimulate recipient PBMC. Cellular responses that can be measured include but are not limited to expressed pro-inflammatory or anti-inflammatory markers, cytokines, proliferation, cytotoxicity, and apoptosis.
Time Perspective: Prospective
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Retention:   Samples With DNA
blood, saliva, intestinal and liver biospy samples, urine, stool
Non-Probability Sample
Individuals who are listed and or recipients of solid organ or bone marrow transplantation.
  • Solid Organ Transplantation
  • Bone Marrow Transplantation
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2020
March 2020   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Recipients of abdominal, thoracic and bone marrow allografts that are receiving inpatient and outpatient follow-up with routine laboratory tests at the University of Pittsburgh Medical Center.
  • All Ages
  • Subject or parents are able to read and understand the informed consent

Exclusion Criteria:

  • Subjects and/or their parents who are unable to read and understand informed consent.
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Contact: Catherine Scott, BS 412-692-7673
Contact: Christine Trautz, BSN 412-692-8472
United States
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Rakesh Sindhi, University of Pittsburgh
University of Pittsburgh
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Principal Investigator: Rakesh Sindhi, MD University of Pittsburgh
University of Pittsburgh
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP