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Trial record 1 of 2 for:    Biomarkers for Post Transplant Lymphoproliferative Disorders in Children
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Biomarkers for Post-Transplant Lymphoproliferative Disorders in Children

This study is currently recruiting participants.
Verified November 2017 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02182986
First Posted: July 8, 2014
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Clinical Trials in Organ Transplantation in Children
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose
Solid organ transplantation is an important therapeutic option for children with a variety of end stage diseases. However, the same immunosuppressive medications that are required to prevent the child's immune system from attacking and rejecting the transplanted organ can predispose these individuals to developing a very serious cancer that is linked to Epstein-Barr virus (EBV).

Condition Intervention
Heart Transplant Small Intestine Transplant Kidney Transplant Liver Transplant EBV-Related PTLD PTLDs Procedure: transplant Drug: Immunosuppressive Drugs

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Biomarkers for Post-Transplant Lymphoproliferative Disorders in Children (CTOTC-06)

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Incidence of Epstein-Barr Virus (EBV) Positive Post-Transplant Lymphoproliferative Disorders (PTLD) [ Time Frame: Receipt of transplanted organ(s) to confirmation of EBV-positive PTLD, up to year 4 post - enrollment ]
    The development of EBV positive PTLD during the study period as assessed by the local site pathologist, with confirmation of the PTLD diagnosis by the Study Clinicopathological Review Board (SCPRB)

  • Specified Gain-of-Function Mutations in EBV Latent Membrane Protein 1 (LMP-1) [ Time Frame: Receipt of transplanted organ(s) to confirmation of mutations in EBV LMP1 , up to year 4 post - enrollment ]
    Specified gain-of-function mutations in EBV LMP-1 (e.g., corresponding to EBV LMP-1 variants G212S or S366T) detected by polymerase chain reaction (PCR) method

  • Pathogenic Changes in B Cell Clonotype Development [ Time Frame: Receipt of transplanted organ(s) to confirmation of changes in B cell clonotype development, up to year 4 post - enrollment ]
    Pathogenic changes in B cell clonotype development as assessed using high throughput sequencing (HTS)


Biospecimen Retention:   Samples With DNA
Blood and tissue samples.

Estimated Enrollment: 1277
Actual Study Start Date: August 14, 2014
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects Enrolled Pre-Transplant

Subjects (N=706) Enrolled Pre-Transplant

  • Subjects with evidence of EBV infection prior to transplant
  • Subjects without evidence of EBV infection prior to transplant, who are at risk of developing EBV infection after transplant
Procedure: transplant
All subjects enrolled in this study are candidates for/recipients of solid organ transplants as a therapeutic for end stage diseases (e.g., heart, liver, heart with liver, kidney, small intestine, or liver with small intestine transplants).
Other Name: transplantation
Drug: Immunosuppressive Drugs
Immunosuppressive drugs prescribed as standard of care to prevent rejection of the allograft.
Other Name: Immunosuppressive Medications
Subjects Enrolled Post-Transplant

Subjects (N=571) Enrolled 3 Yrs Post-Transplant

  • Subjects with evidence of EBV infection prior to transplant
  • Subjects without evidence of EBV infection prior to transplant, who are at risk of developing EBV infection after transplant
Procedure: transplant
All subjects enrolled in this study are candidates for/recipients of solid organ transplants as a therapeutic for end stage diseases (e.g., heart, liver, heart with liver, kidney, small intestine, or liver with small intestine transplants).
Other Name: transplantation
Drug: Immunosuppressive Drugs
Immunosuppressive drugs prescribed as standard of care to prevent rejection of the allograft.
Other Name: Immunosuppressive Medications

Detailed Description:
EBV-associated post-transplant lymphoproliferative disease (PTLD) is the most common malignancy in children after transplant. Diagnosis and effective treatment of the EBV-associated cancer is hampered by our inability to determine which children are at risk of developing these cancers and to detect the cancer at an early stage. In this study, we plan to test new "biomarkers" in the blood of children that will tell us very early on if the child is at risk of developing the EBV-associated cancer or if the cancer is present. These studies provide new opportunities for detection, diagnosis, and treatment of children with EBV-associated, post-transplant cancer.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric Candidates for or recipients of heart, liver, heart with liver, kidney, small intestine, or liver with small intestine at participating major pediatric solid organ transplant programs
Criteria

Inclusion Criteria:

  • Subject and/or parent or legal guardian must be able to understand and provide informed consent/assent;
  • Candidate for or recipient of: heart, liver, heart with liver, small intestine, liver with small intestine, or kidney; and
  • Subject enrolled within 3 years of transplant.

Exclusion Criteria:

  • Previous diagnosis of PTLD;
  • Transplant recipients of lung alone, or in combination with an eligible organ type;
  • Pancreas transplantation with the exception of 'en bloc' transplant in combined liver and small intestine multivisceral transplantation;
  • Any combination other than listed in inclusion criteria;
  • History of any previous solid organ, stem cell, or bone marrow transplantation;
  • Inability or unwillingness of the legal guardian and/or the subject to comply with the study protocol.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02182986


Locations
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Susan Feist, RN    310-825-4349    sfeist@mednet.ucla.edu   
Principal Investigator: Robert S. Venick, MD         
Lucile Packard Children's Hospital Stanford Recruiting
Stanford, California, United States, 94305
Contact: Sheri Krams, PhD    650-498-6246    smkrams@stanford.edu   
Principal Investigator: Carlos Esquivel, MD, PhD         
United States, District of Columbia
Medstar Georgetown Transplant Institute Recruiting
Washington, District of Columbia, United States, 20057
Contact: Catherine Lopez    202-444-1769    Catherine.lopez@medstar.net   
Principal Investigator: Thomas Fishbein, MD         
United States, Florida
University of Miami Health System Recruiting
Miami, Florida, United States, 33101
Contact: Sandra Flores    305-519-1788    sflores@med.miami.edu   
Principal Investigator: Akin Tekin, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Andre Hawkins, MA    513-803-7164    andre.hawkins@cchmc.org   
Principal Investigator: Clifford Chin, MD         
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Christine Trautz    412-692-8472    trautzcm@upmc.edu   
Principal Investigator: George Mazariegos, MD         
United States, Texas
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75235
Contact: Jatin Moghe    214-456-3533    jatin.moghe@childrens.com   
Principal Investigator: Dev M. Desai, MD, PhD         
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Clinical Trials in Organ Transplantation in Children
Investigators
Principal Investigator: Carlos Esquivel, M.D., Ph.D. Stanford University
Study Chair: Daniel Bernstein, M.D. Stanford University
  More Information

Additional Information:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02182986     History of Changes
Other Study ID Numbers: DAIT CTOTC-06
First Submitted: June 30, 2014
First Posted: July 8, 2014
Last Update Posted: November 20, 2017
Last Verified: November 2017

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Biomarkers
Post-Transplant Lymphoproliferative Disorders (PTLDs)

Additional relevant MeSH terms:
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs