Blood test could replace needle biopsy for liver rejection
NCT ID NCT06153641
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether a blood test measuring CK-18, a protein released when liver cells die, can spot organ rejection after a liver transplant. Currently, doctors use a liver biopsy, which involves inserting a needle into the body and carries risks. Researchers will collect blood samples from 70 liver transplant patients and compare CK-18 levels to standard tests, aiming to develop a safer, non-invasive way to detect rejection.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to a simple blood test to detect liver transplant rejection, reducing the need for risky biopsies.
- What could go wrong
- This is an early observational study with only 70 participants, so results may not apply broadly. The test may not prove accurate enough to replace biopsies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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70 people
The number who actually took part.
- Started
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Apr 2019
- Expected to finish
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Mar 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Three specific cohorts of subjects as follows (no randomization of subjects): 1. Post-transplant patients undergoing standard of care liver biopsy (Biopsy arm). 2. Stable post-liver transplantation patients without rejection (Stable post-liver transplant arm). 3. Healthy non-transplant control patients without liver disease (Healthy arm).
- Ages
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1 year and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients should be at least 1 year of age at enrollment. * There shall be no restrictions regarding sex, race or ethnicity * All Patients who have received a liver transplant will be approached for enrollment in the study. Study Group-Specific Inclusion Criteria: • The patients who are scheduled for a liver biopsy for suspicion of liver transplant rejection (Biopsy arm). Note-1: If a patient gets a subsequent episode of rejection and the patient is scheduled for another liver biopsy after completing participation in the biopsy arm, it will make the patient eligible for re-enrollment in the study under the biopsy arm since this study captures the rejection events. The patient will be re-consented each time and given a new participant ID each time. Note-2: If the patient gets stable in the study doctor's opinion after completing participation in the biopsy arm, it will make the patient eligible for re-enrollment in the study under the stable post-liver transplant arm. The patient will be re-consented and given a new participant ID. Control Group specific inclusion Criteria: • Healthy non transplant controls(Healthy arm). Note-1: If a patient gets a liver transplant after completing participation in a healthy arm, it will make the patient eligible for re-enrollment in the study under other arms (stable post-liver transplant arm or biopsy arm). The patient will be re-consented each time and given a new participant ID each time. • Liver transplant recipients without rejection: Patients who are 'stable' post liver transplantation would be approached (Stable post-liver transplant arm). Note-1: If a patient gets an episode of rejection after completing participation in the stable arm, it will make the patient eligible for re-enrollment in the study under the biopsy arm since this study captures the rejection events. The patient will be re-consented each time and given a new participant ID each time. Exclusion Criteria for All Arms: 1. Known infectious hepatitis 2. Patient non-compliant 3. For patients with any unforeseen risk factors, all efforts will be made to not enroll them in the study. If a patient has exceeded the 50mL/3mL per kg limit clinically, the patient will not be enrolled in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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SSM Health Cardinal Glennon Children's Hospital & Saint Louis University Hospital (SSM Health- SLU Hospital)
St Louis, Missouri, 63104, United States
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