رادار التجارب AI | ||
|---|---|---|
حالة التجربة السريرية NCT06153641 لـ رفض زراعة الكبد، فشل ورفض زراعة الكبد هي نشط (لا يقبل مشاركين جدد). اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
جامعة سانت لويسCytokeratin 18 Non-invasive Biomarker for Rejection in Liver Transplant Patients ٧٠ غير جراحي موجه بالمؤشرات الحيوية
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
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
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 |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
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.
جامعة سانت لويسMid-America TransplantMissouri