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

NCT06153641 | Active Not Recruiting

• 1 other identifier: 29508
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Transplant Rejection; Liver Transplant Failure and Rejection

Keywords

Liver Transplant; Stable post liver transplant; Post transplant liver biopsy; Healthy nontransplant without liver disease

Outcome Measures

Primary Outcomes (3)

• Characterize baseline CK-18 levels in healthy non transplant control patients and 'stable' post transplantation patients without rejection.

  Characterize baseline CK-18 levels in healthy non transplant control patients and 'stable' post transplantation patients without rejection.

  through study completion, an average of 1 year

• Determine cross-sectional relationship between CK-18 levels and severity of rejection.

  Determine cross-sectional relationship between CK-18 levels and severity of rejection.

  through study completion, an average of 1 year

• Ultimate goal would be to determine if serial CK-18 assessment could longitudinally predict rejection and its progression.

  Our ultimate goal would be to determine if serial CK-18 assessment could longitudinally

  through study completion, an average of 1 year

Study Arms (3)

Biopsy arm

Post-transplant patients undergoing standard of care liver biopsy (Biopsy arm).

Other: N/A-Observational Study

Stable post-liver transplant arm

Stable post-liver transplantation patients without rejection (Stable post-liver transplant arm).

Other: N/A-Observational Study

Healthy arm

Healthy non-transplant control patients without liver disease (Healthy arm).

Other: N/A-Observational Study

Interventions

N/A-Observational Study OTHER

N/A-Observational Study

Biopsy arm; Healthy arm; Stable post-liver transplant arm

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• Known infectious hepatitis
• Patient non-compliant
• 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.

Sponsors & Collaborators

• St. Louis University: lead
• Mid-America Transplant: collaborator

Study Sites (1)

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

St Louis, Missouri, 63104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum collected from 5ml of blood will be stored.

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Ajay Jain, MD

  Saint Louis University/SSM Health Cardinal Glennon Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Director of Pediatric Gastroenterology and Hepatology

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: December 1, 2023
• Study Start: April 16, 2019
• Primary Completion: January 13, 2025
• Study Completion: March 31, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

US (1)