NCT06346665

Brief Summary

Medical data and biological samples obtained from transplant patients are collected and managed across Germany with the help of the DZIF Transplant Cohort. The data and samples form the basis of scientific studies which investigate the connections between numerous factors influencing an organ's susceptibility to infection and organ function.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Jan 2016Dec 2030

Study Start

First participant enrolled

January 1, 2016

Completed
8.2 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Expected
Last Updated

April 23, 2024

Status Verified

March 1, 2024

Enrollment Period

9.9 years

First QC Date

March 26, 2024

Last Update Submit

April 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Realisation of studies that focus on the the medical needs of transplant patients, particularly with regard to their susceptibility to infection

    Provision of collected data and biosamples to research groups for the realisation of scientific studies with a number of resources that individual clinics could not provide on their own

    10 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of any age who have received a kidney, pancreas, liver, heart or stem cell transplant at one of the listed partner centres

You may qualify if:

  • Consent
  • undergone transplantation of kidney, pancreas, liver, heart or stem cells

You may not qualify if:

  • No consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technische Universität München

München, Germany

RECRUITING

Related Publications (2)

  • Karch A, Schindler D, Kuhn-Steven A, Blaser R, Kuhn KA, Sandmann L, Sommerer C, Guba M, Heemann U, Strohaker J, Glockner S, Mikolajczyk R, Busch DH, Schulz TF; for the Transplant Cohort of the German Center for Infection Research (DZIF Transplant Cohort) Consortium. The transplant cohort of the German center for infection research (DZIF Tx-Cohort): study design and baseline characteristics. Eur J Epidemiol. 2021 Feb;36(2):233-241. doi: 10.1007/s10654-020-00715-3. Epub 2021 Jan 25.

  • Sommerer C, Schroter I, Gruneberg K, Schindler D, Behnisch R, Morath C, Renders L, Heemann U, Schnitzler P, Melk A, Della Penna A, Nadalin S, Heeg K, Meuer S, Zeier M, Giese T; Transplant Cohort of the German Center for Infection Research (DZIF Transplant Cohort) Consortium. Incidences of Infectious Events in a Renal Transplant Cohort of the German Center of Infectious Diseases (DZIF). Open Forum Infect Dis. 2022 May 13;9(7):ofac243. doi: 10.1093/ofid/ofac243. eCollection 2022 Jul.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood (Serum, plasma, RNA-stabilized, purified PBMC, buffy coat) Stool Urine Buccal swabs

MeSH Terms

Conditions

Infections

Central Study Contacts

Daniela Schindler, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2024

First Posted

April 4, 2024

Study Start

January 1, 2016

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2030

Last Updated

April 23, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

The use of collected data and biosamples is possible on the basis of an application to the Scientific Steering Committee of the transplant cohort. Cooperations with members of the cohort are welcome

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
The use of resources is possible after successful review of the preliminary and main application to the transplant cohort by the internal Scientific Steering Committee and - depending on the study design - external reviewers
More information

Locations