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세인트루이스 대학교Cytokeratin 18 Non-invasive Biomarker for Rejection in Liver Transplant Patients 70 비침습 바이오마커 기반
Cytokeratin 18 a Novel Non-invasive Biomarker for Rejection in Liver Transplant Patients
- 29508
Stable post liver transplant
Post transplant liver biopsy
Healthy nontransplant without liver disease
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
Biopsy arm Post-transplant patients undergoing standard of care liver biopsy (Biopsy arm). | N/A-Observational Study N/A-Observational Study |
Stable post-liver transplant arm Stable post-liver transplantation patients without rejection (Stable post-liver transplant arm). | N/A-Observational Study N/A-Observational Study |
Healthy arm Healthy non-transplant control patients without liver disease (Healthy arm). | N/A-Observational Study N/A-Observational Study |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
- 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.
- 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.
세인트루이스 대학교Mid-America TransplantMissouri