RECRUITING

International (Pediatric) Peritoneal Biobank

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Within few years the peritoneal membrane of adult peritoneal dialysis (PD) patients undergoes substantial morphological transformation, including progressive fibrosis, vasculopathy and neoangiogenesis. Ultrafiltration capacity steadily declines and ultimately results in PD failure. In children, peritoneal biopsies demonstrating PD associated alterations have not yet been obtained. They, however, should be particularly informative, since secondary tissue and vascular pathology related to ageing or diabetes is absent. An international, prospective peritoneal membrane biopsy study in children on PD will therefore be performed. Biopsies will be obtained at time of PD catheter insertion, on occasion of intercurrent abdominal surgery (e.g. hernia repair, catheter exchange) and at time of renal transplantation. Quantitative histomorphometry and tissue protein expression analyses will be correlated with time integrated PD treatment modalities and functional characteristics as well as inflammatory and cardiovascular comorbidity surrogate parameter. Blood will be obtained during clinical routine sampling. Biopsies will be obtained during clinically indicated operations, without substantially increasing operation time and associated surgical risks. The detailed histomorphometry of the PD membrane will give additional information, potentially impacting on the individual PD regime. 3/2018: The analyses of the pediatric PD biopsy demonstrated early and major transformation of the peritoneal membrane with neutral pH low GDP fluids, and significant vasculopathy already in children with CKD stage 5, further progressing with PD. The underlying mechanisms are partly understood, only. In view of these major findings and the numerous open questions, collection of biosamples will be continued in children and also in adult PD patients. The following questions will be addressed: Molecular counterparts of peritoneal semi-permeability, solute and water transport (beyond AQP1), pathomechanisms and molecular and functional impact of peritoneal transformation with low and high GDP fluids, and the respective pathomechanisms and molecular and functional impact of vascular disease in CKD and with different PD fluids. The impact of renal transplantation following PD will be assessed in a subgroup of patients with tenckhoff catheter removal several weeks after transplantation and a functioning graft.

Official Title

International (Pediatric) Peritoneal Biobank

Quick Facts

Study Start:2011-02
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01893710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Day to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Abdominal adhesions, malformation and inflammation beyond PD induced changes
  2. * Patients with disseminated tumour disease
  3. * Patients with critical heart failure and other medical conditions, where the additional procedure may confer an increased increase risk
  4. * Pregnancy
  5. * Preterm babies (below 37 weeks of gestational age)
  6. * Serum hemoglobin \< 10 g/dl in newborns and \< 8 g/dl in children and adults

Contacts and Locations

Study Contact

Claus P Schmitt, Prof
CONTACT
+49 6221 56
claus.peter.schmitt@med.uni-heidelberg.de

Principal Investigator

Claus P Schmitt, MD
PRINCIPAL_INVESTIGATOR
University of Heidelberg, Center for Pediatric and Adolescent Medicine

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
The Children´s Hospital of Philadelphia
Narberth, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Heidelberg University

  • Claus P Schmitt, MD, PRINCIPAL_INVESTIGATOR, University of Heidelberg, Center for Pediatric and Adolescent Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2011-02
Study Completion Date2028-12

Study Record Updates

Study Start Date2011-02
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • peritoneal dialysis
  • parietal peritoneum
  • omentum
  • chronic kidney disease
  • vasculopathy

Additional Relevant MeSH Terms

  • Kidney Failure, Chronic
  • Peritoneal Dialysis Complication
  • Transplantation
  • Healthy