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Biomarkers for Post-Transplant Lymphoproliferative Disorders in Children

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ClinicalTrials.gov Identifier: NCT02182986
Recruitment Status : Active, not recruiting
First Posted : July 8, 2014
Last Update Posted : September 18, 2018
Sponsor:
Collaborator:
Clinical Trials in Organ Transplantation in Children
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
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 or disease Intervention/treatment
Heart Transplant Small Intestine Transplant Kidney Transplant Liver Transplant EBV-Related PTLD PTLDs Procedure: transplant Drug: Immunosuppressive Drugs

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.

Study Type : Observational
Actual Enrollment : 945 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Biomarkers for Post-Transplant Lymphoproliferative Disorders in Children (CTOTC-06)
Actual Study Start Date : August 14, 2014
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

Group/Cohort Intervention/treatment
Subjects Enrolled Pre-Transplant

Subjects (N=approximately 357) 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=approximately 588) 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




Primary Outcome Measures :
  1. 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)

  2. 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

  3. 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.


Information from the National Library of Medicine

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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.

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
Los Angeles, California, United States, 90095
Lucile Packard Children's Hospital Stanford
Stanford, California, United States, 94305
United States, District of Columbia
Medstar Georgetown Transplant Institute
Washington, District of Columbia, United States, 20057
United States, Florida
University of Miami Health System
Miami, Florida, United States, 33101
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75235
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

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 Posted: July 8, 2014    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

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