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ACTIVE NOT RECRUITING

NCT06153641

Cytokeratin 18 Non-invasive Biomarker for Rejection in Liver Transplant Patients

Sponsor: St. Louis University

View on ClinicalTrials.gov

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.

Official title: Cytokeratin 18 a Novel Non-invasive Biomarker for Rejection in Liver Transplant Patients

Key Details

Gender

All

Age Range

1 Year - Any

Study Type

OBSERVATIONAL

Enrollment

Start Date

2019-04-16

Completion Date

2026-03-31

Last Updated

2025-12-10

Healthy Volunteers

Yes

Conditions

Liver Transplant Rejection Liver Transplant Failure and Rejection

Interventions

OTHER

N/A-Observational Study

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.

Locations (1)

SSM Health Cardinal Glennon Children's Hospital & Saint Louis University Hospital (SSM Health- SLU Hospital)

St Louis, Missouri, United States