Netherlands

TransplantLines Biobank and Cohort Study

TransplantLines is designed as a single-centre, prospective cohort study and biobank including all different types of solid organ transplant recipients as well as living organ donors. Data will be collected from transplant candidates before transplantation, during transplantation, at 3 months, 6 months, 1 year, 2 years and 5 years, and subsequently every 5 years after transplantation. Data from living organ donors will be collected before donation, during donation, at 3 months, 1 year and 5 years after donation, and subsequently every 5 years. The primary outcomes are mortality and graft failure. The secondary outcomes will be cause-specific mortality, cause-specific graft failure and rejection. The tertiary outcomes will be other health problems, including diabetes, obesity, hypertension, hypercholesterolaemia and cardiovascular disease, and disturbances that relate to quality of life, that is, physical and psychological functioning, including quality of sleep, and neurological problems such as tremor and polyneuropathy.

Key facts

Name of the connected EIT Health partner: University Medical Center Groningen
Number of individuals: 3000
Biobank confirmed willingness to provide samples/data for EIT Health studies: Yes
Contact person(s) and contact data
(e-mail address, tel. no) for access purposes:
Prof. dr. S.J.L. Bakker, s.j.l.bakker@umcg.nl, +31503616161; Dr. L.M. Kieneker, l.m.kieneker@umcg.nl, +31503616161
Number of samples:
Sample type: Tissue; Whole blood; Buffy Coat; Plasma; Serum; Urine; Faeces; Hair; Nails; Solid organ transplant patients and living donors
Website: www.umcg.nl/NL/UMCG/Afdelingen/Transplantatiecentrum/onderzoek/transplantlines/

General information

Type of biobank: Clinical/disease specific;
If longitudinal the frequency: Transplantation patients will have several visits in 10 years (screening, transplantation, and 3 months after transplantation, 6 months after transplantation, 1 year after transplantation, 2 years after transplantation, 5 years after transplantation, 10 years after transplantation). Living donors also have several visits in 10 years (screening, donation, 3 months after donation, 1 year after donation, 5 years after donation, 10 years after donation).
Link to central portal to seek samples and data:
Broad consent: Yes
Option to recall donors: Yes
Option to recall family members: No

Biobank access procedure:

Major terms for access: A data/sample request form has to be completed to apply for access. This apllication will be judged by the TransplantLines working group.
Ethical and legal compliance: A data transfer agreement and/or material agreement is needed upon sharing data/material.
Speed and reliability of delivery:
Pricing:

Quality management system:

Storage: Blood, 24-hour urine, faeces, nails and hair will be collected from the participants at each TransplantLines
visit. Participants will be instructed to collect a 24-hour urine sample according to strict protocol on the day
before their visit to the outpatient clinic, that is, discard their morning urine specimen, collect all subsequent
urine throughout the next 24 hours and include the next morning’s first specimen of the day of the visit to the outpatient clinic. Blood will be drawn after an overnight fasting period of 8–12 hours in the morning after completion of the 24-hour urine collection. Blood drawing and receipt of the collected 24-hour urine samples are performed by experienced nurses at our outpatient clinic.

As blood samples, one serum tube of 10mL, two EDTA samples of 10mL, one citrate tube of 6mL, one lithium-heparin tube of 10mL and one PAXgene tube of 10mL will be collected from each participant at each TransplantLines visit. Subsequently, tubes will be centrifuged by technicians at 1300g for 10min, except for the citrate tube which is centrifuged at 2500g for 10min. Of the 24-hour urine collection, three urine tubes will be collected, of which one tube will be partially acidified. All blood and urine samples will be subsequently aliquoted by technicians and shipped to the core laboratory for storage in −80°C (−112°F) freezers (Panasonic, ‘s-Hertogenbosch, The Netherlands). Blood and urine samples will be analysed in the following years for multiple research questions that will arise.

Participants will be asked to collect a faeces sample the day prior to the TransplantLines visit. A FecesCatcher
(TAG Hemi VOF, Zeijen, The Netherlands) will be sent to the patient’s home, and faeces sample will be collected in appropriate tubes and frozen immediately after collection. The participant will transport the faeces sample in cold storage (with ice cubes or in a cooler) to the TransplantLines visit the following day. Subsequently, the faeces sample will be immediately stored at −80°C (−112°F). Faeces samples will be primarily used for microbiome analyses. Solid organ transplant recipients have a shift in the gut microbiome with a decrease in predominant
organisms, a loss of bacterial diversity and emergence of new dominant population. These may result in increased
risk of infection, rejection and mortality. Therefore, we would like to examine the gut microbiome in relation to
the development of health problems after transplantation.

Additional blood and urine samples will also be collected in the event of worsening graft function and an organ transplant biopsy is indicated. Prior to the biopsy, one serum tube of 10mL, two EDTA samples of 10mL, one citrate tube of 6mL, one lithium-heparin tube of 10mL and one PAXgene tube of 10mL will be collected. At the same time, one serum tube of 10mL, one EDTA sample of 10mL and one spot urine sample of 10mL will be collected and directly stored on ice to prevent (ongoing) in vitro complement activation.

Furthermore, during transplant surgery and transplant biopsies, tissue samples will be collected of the transplanted organ and surrounding tissues, including fat, skin, ureter, tracheal, biliary, and arterial and venous
tissues, that have been discarded as pathological waste.

Compliance with international standards:
Current ISO certificates:

Data:

Clinical data linked to samples: Questionnaire data; Clinical data; Phenotypic data; At each visit as described earlier, clinical laboratory measurements requested by the physician will be included in the study database on patient consent. Blood pressure will be measured, anthropometry measurements will be performed, hand grip strength will be assessed, and body composition will be determined.
Data standards:
Data security rules:

Biobank related service:

Research support, what type of expertise?:
Core facility services; what type? Link?:
Queries from national health registers:
Links to the model contract and MTA:

IP:

IP rules, what is negotiable?:
Requirements to study results (access etc.):
Participant’s right to the information:
Number of access contracts with industry:

COVID-19 samples:

Access to biological samples from patients with COVID-19?

  • Serum
  • Full blood (for RNA extraction)
  • EDTA-Full blood (for DNA extraction)
  • EDTA-Plasma
  • Citrate-Plasma
  • PBMC (Peripheral Blood Mononuclear Cells)
  • Nasopharyngeal aspirate
  • Tracheal aspirate
Contact person(s) and contact data (e-mail address, tel. no) for access purposes