A prospective study to identify clinically relevant biomarkers for early detection of progression analysis of NAFLD to NASH - NI

Strand Life Sciences Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

试验速览

暂无简介。

•Affected Arm:
•1.Clinically confirmed ? NAFLD with significant fibrosis (LSM =8.2 kPa), NAFLD with advanced fibrosis (=9.7 kPa), and NAFLD-cirrhosis (=13.6 kPa) ? cases based on the following (as available):
•2.Adults aged 18 years to 75 years
•3.Adults capable of giving a written informed consent to participate
•4.Fibroscan, Ultrasound, CT, or MR imaging confirming hepatic steatosis
•5.Fibroscan (or histological) evidence of Significant fibrosis (LSM =8.2 kPA), or Advanced Fibrosis (=9.7 kPa), or cirrhosis (LSM =13.6 kPa)
•6.BMI Kg/m2 - 18 and above
•Control Arm:
•1.Cases that are NAFLD without significant fibrosis
•2.Adults aged 18 years to 75 years
•3. Adults capable of giving a written informed consent to participate
•4. Fibroscan, Ultrasound, CT, or MR imaging confirming hepatic steatosis
•5. Fibroscan (or histological) evidence documenting absence of significant fibrosis (LSM <8.2 kPa)

•1.Patients not consenting or unable to give an informed written consent
•2.Recent long-term (12 months or more) or concomitant use of agents known to cause hepatic steatosis (systemic use of corticosteroids, amiodarone, methotrexate, tamoxifen, tetracycline, high dose oestrogens, valproic acid)
•3.Patients not meeting the inclusion criteria or judged by the investigator to be unsuitable for inclusion into the study
•4.Patients having concomitant Hepatitis B, or Hepatitis C or any other etiology of liver disease

发起方