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NCT06153641 · ClinicalTrials.gov registry record
Cytokeratin 18 Non-invasive Biomarker for Rejection in Liver Transplant Patients
A clinical trial of Liver Transplant Rejection and Liver Transplant Failure and Rejection, sponsored by St. Louis University.
- Active
- Registry status
- 70
- Enrollment target
- 1
- Study location
NCT06153641: Active study of Liver Transplant Rejection and Liver Transplant Failure and Rejection, sponsored by St. Louis University.
NCT06153641 is a study of Liver Transplant Rejection and Liver Transplant Failure and Rejection that is active but no longer recruiting, run by St. Louis University. The registered enrollment target is 70 participants, above the 31-participant average among 3 other Liver Transplant Rejection trials with a reported enrollment target (126% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06153641, a study of Liver Transplant Rejection and Liver Transplant Failure and Rejection, is active but no longer recruiting, sponsored by St. Louis University.
- ACTIVE NOT RECRUITING
- Registry status
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
Liver transplantation is a lifesaving procedure; however, there are chances that the body may reject the organ following liver transplantation, and this remains a significant concern. This rejection of the transplanted, healthy liver tissue further adds to the patient's illness and also increases the related costs of treatment. Currently, liver biopsy is the standard procedure used for diagnosing this rejection. Being an invasive procedure (requiring the introduction of instruments into the body), this procedure also increases the chances of death of the patient. Researchers are looking into the identification of testing methods that can act as a sign of this rejection without requiring the introduction of instruments into the body. This type of testing could also allow for adjusting the doses of drugs given to the patient to decrease the chances of graft failure. A particular event that occurs during rejection in the body is the death of liver cells. Thus, tracking cell death using a blood test would be an important tool in assessing rejection. CK-18 is a protein in the liver cells that is thought to be linked to the changes occurring as a result of cell death. This study will be looking into a new idea of measuring CK-18 levels and compare them to an existing index to develop a reliable test for liver transplant rejection without introducing any instruments into the body. The purpose of this research study is to assess the history and collect blood samples to be tested for measuring CK-18 levels and assess certain other markers in the blood.
Primary Outcome
Characterize baseline CK-18 levels in healthy non transplant control patients and 'stable' post transplantation patients without rejection.
Conditions Studied
Interventions
- OTHER N/A-Observational Study
Study Locations (1)
Missouri
- SSM Health Cardinal Glennon Children's Hospital & Saint Louis University Hospital (SSM Health- SLU Hospital) - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2019-04-16 |
| Est. Completion | 2026-03-31 |
What the registry record for NCT06153641 still lists
NCT06153641 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 31-participant average among 3 other Liver Transplant Rejection trials with a reported enrollment target (126% higher).
The record links to 2 conditions, with Liver Transplant Rejection appearing as the primary indexed condition, and to 1 intervention - of which N/A-Observational Study is the first listed.
NCT06153641 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT06153641 about?
NCT06153641 is a clinical study titled "Cytokeratin 18 Non-invasive Biomarker for Rejection in Liver Transplant Patients". Liver transplantation is a lifesaving procedure; however, there are chances that the body may reject the organ following liver transplantation, and this remains a significant concern. This rejection of the transplanted, healthy liver tissue further adds to the patient's illness and also increases th...
What is the current status of trial NCT06153641?
This trial is currently active not recruiting. The enrollment target is 70 participants. The study started on 2019-04-16. Estimated completion is 2026-03-31.
What conditions does trial NCT06153641 study?
This clinical trial studies the following conditions: Liver Transplant Rejection, Liver Transplant Failure and Rejection.
What interventions are being tested in trial NCT06153641?
The interventions under investigation include: N/A-Observational Study (OTHER).
Who is sponsoring clinical trial NCT06153641?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06153641 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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