Epidemiologic Liver Outcomes Retrospective Study to Confirm The Prognostic Value of the FibroNest Digital Pathology Fibrosis Biomarker (Ph-FCS) in Patients With MASLD (DPAILO-2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,519
- 试验地点
- 2
- 主要终点
- Performance of Hepatic Decompensation Event predictive value of the FibroNest Ph-FCS
研究概览
简要总结
The aim of this multi-center, retrospective epidemiologic study is to confirm the prognostic performance of the Digital Pathology (DP) FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS), derived from standard digital pathology liver biopsy images, in predicting clinical hepatic decompensation events in patients with metabolic dysfunction-associated steatohepatitis (MASH).
详细描述
MASH (Metabolic Dysfunction-Associated Steatohepatitis):
MASH presents histological liver changes similar to those caused by alcohol abuse, but occurs in the absence of alcohol intake. It is common among adults with conditions such as obesity and type-2 diabetes. Severe MASH is expected to become a leading cause of end-stage liver disease.
Current Challenges:
There are currently no fully approved treatments for MASH which places a significant burden on liver health and transplantation. Diagnosis and assessment rely on subjective histological reviews, which are prone to variability and limitations in detecting subtle changes. Therefore, there is an urgent need for accurate and continuous histological biomarkers.
FibroNest Ph-FCS Solution:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •From NCT01030484:
- •Age at least 18 years during the consent process
- •Willingness to be in the study for 1 or more years
- •Ability and willingness to give written, informed consent to be screened for and, if eligible, to be enrolled into the Database 2 study
- •Minimal or no alcohol use history consistent with NAFLD (see
排除标准
- •Collection of a liver biopsy that is obtained within 120 days of enrollment as part of standard of care or for evaluation in FLINT trial
- •Collection of biosamples (serum, plasma, DNA, and, if available, liver tissue) within 90 days prior to enrollment and 0-90 days before or 4-90 days after the standard of care liver biopsy
- •Exclusion Criteria:
- •From NCT01030484
- •Clinical or histological evidence of alcoholic liver disease or alcohol consumption during the two years before entry (> 20g/day for men, >10g/day women)
- •History of total parenteral nutrition
- •History of gastric or jejunoileal bypass preceding the diagnosis of NAFLD
- •Biliopancreatic diversion or bariatric surgery
- •Evidence of advanced liver disease with Child-Pugh-Turcotte score equal to or greater than 10
- •Short bowel syndrome
- •Suspected or confirmed hepatocellular carcinoma
- •Positive for HIV
- •Evidence of HBV or HCV infection
- •Low alpha-1-antitrypsin level and ZZ phenotype
- •Wilson's disease
- •Known glycogen storage disease, dysbetalipoproteinemia, phenotypic hemochromatosis
- •Vascular lesions
- •Iron overload greater than 3+
- •Zones of confluent necrosis, infarction, massive or sub-massive, pan-acinar necrosis
- •Multiple epithelioid granulomas
- •Congenital hepatic fibrosis
- •Polycystic liver disease
- •Other metabolic or congenital liver disease
研究组 & 干预措施
Liver Related Event
Liver-related events include liver-related death, hepatic decompensation events (variceal hemorrhage, ascites, hepatic encephalopathy), and hepatocellular carcinoma.
干预措施: Digital Pathology FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS) (Diagnostic Test)
Non-Liver Related Event
Absence of any of the liver events described in the second group in the patient clinical follow-up.
干预措施: Digital Pathology FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS) (Diagnostic Test)
结局指标
主要结局
Performance of Hepatic Decompensation Event predictive value of the FibroNest Ph-FCS
时间窗: Time-to-event analysis between 2 and 10 years
Area under Receiver Operating Characteristic Curve (AUROC) of the FibroNest Ph-FCS, as a prognostic/diagnostic biomarker for liver related events in patients with MASH.
次要结局
- Performance of Hepatic Decompensation Event predictive value of the NASH-CRN Fibrosis Stage(Time-to-event analysis between 2 and 10 years)
- Performance of Hepatic Decompensation Event predictive value of the elastography (Fibroscan) biomarker, a non-invasive test(Time-to-event analysis between 2 and 10 years)
- Performance of Hepatic Decompensation Event predictive value of available non-invasive biomarkers (NITs) including Fib-4 and Elastography by measured by Fibroscan(Time-to-event analysis between 2 and 10 years)
- Performance of Hepatic Decompensation Event predictive value of the Collagen Area Ratio (CAR%) as measured by FibroNest(Time-to-event analysis between 2 and 10 years)