Status:
ACTIVE_NOT_RECRUITING
Cytokeratin 18 Non-invasive Biomarker for Rejection in Liver Transplant Patients
Lead Sponsor:
St. Louis University
Collaborating Sponsors:
Mid-America Transplant
Conditions:
Liver Transplant Rejection
Liver Transplant Failure and Rejection
Eligibility:
All Genders
1+ years
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 o...
Detailed Description
Cellular rejection following liver transplantation is of worldwide occurrence and a major cause of morbidity affecting 15 to 20 percent of liver transplantation recipients. Elevation of serum aminotra...
Eligibility Criteria
Inclusion
- 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:
- 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.
Exclusion
Key Trial Info
Start Date :
April 16 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06153641
Start Date
April 16 2019
End Date
March 31 2026
Last Update
December 10 2025
Active Locations (1)
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1
SSM Health Cardinal Glennon Children's Hospital & Saint Louis University Hospital (SSM Health- SLU Hospital)
St Louis, Missouri, United States, 63104