Machine Learning for Prediction of Therapy Response in Autoimmune Hepatitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5,000
- 试验地点
- 2
- 主要终点
- Number of patients with complete biochemical response at 6 months after diagnosis
研究概览
简要总结
The 5th International Autoimmune Hepatitis Group (IAIHG) research workshop emphasized the integration of large clinical cohorts with artificial intelligence (AI) for enhanced prediction of therapy responses and outcomes in Autoimmune Hepatitis (AIH). This project aims to develop and validate machine learning (ML) models using data from the R-Liver registry and other international cohorts. After rigorous preprocessing to ensure data uniformity and quality, the investigators will identify and characterize factors influencing therapy response. They will then implement ML models to predict complete biochemical response (CBR) at 6 and 12 months, using five-fold cross-validation, and validate these models in external cohorts from Spain, Canada, and the international AIH group, ensuring robustness and generalizability.
Finally, the investigators will prospectively validate the models in newly registered cases, assessing both short-term and long-term outcomes. This project seeks to advance personalized treatment strategies in AIH, facilitating timely adjustments in therapy and improving patient prognosis through AI-driven decision support. This projects' interdisciplinary team, with expertise in clinical AI and hepatology, is well-equipped to address these challenges and enhance the clinical management of AIH.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Autoimmune hepatitis
- •Consent to provide data to the specific registry
- •available follow-up data at least within the first 12 months
排除标准
- •variant syndromes
- •extrahepatic autoimmune disease
- •immunosuppressive treatment at diagnosis
研究组 & 干预措施
CANAL Registry
IAIHG Registry
ColHAI Registry
R-LIVER Registry
AIH registry from Edmonton, Canada
结局指标
主要结局
Number of patients with complete biochemical response at 6 months after diagnosis
时间窗: 6 months
Complete biochemical response is defined as normal aspartate amino transferase (AST), alanine aminotransferase (ALT) and immunoglobulin G (IgG).
Number of patients with complete biochemical response at 12 months after diagnosis
时间窗: 12 months
Complete biochemical response is defined as normal aspartate amino transferase (AST), alanine aminotransferase (ALT) and immunoglobulin G (IgG).
次要结局
- Number of patients experiencing liver-related death or liver transplantation(From enrolment until the end of the study)
- Number of patients with decompensation of liver disease(From enrolment until the end of the study)
- Number of patients with complete biochemical response through study completion(through study completion, an expected average of 1 year)
- Number of patients with histological remission of AIH through study completion(through study completion, an expected average of 1 year)
- Number of patients that develop cirrhosis through study completion(through study completion, an expected average of 1 year)
- Number of patients with intolerance to primary treatment necessitating regimen change(12 months)
- Number of patients with non-response to primary treatment necessitating treatment change(12 months)
- Number of patients with third line treatment due to non-response to obtain biochemical response through study completion(through study completion, an expected average of 1 year)
- Number of patients with normalization of aminotransferase levels in the blood irrespective of Immunoglobulin G levels(6 months)
- Number of patients with normalization of aminotransferase levels irrespective of Immunoglobulin G levels(12 months)
- Number of patients with steroid-free complete biochemical response(6 months)
- Number of patients with steroid-free complete biochemical response(12 months)
研究者
Engel, Bastian Dr.
Gastroenterologist, Clinician Scientist, Principal Investigator
Hannover Medical School