Identification of clinically relevant biomarkers for early detection of progression analysis of NAFLD to NASH
- Conditions
- Health Condition 1: K740- Hepatic fibrosis
- Registration Number
- CTRI/2023/12/060718
- Lead Sponsor
- Strand Life Sciences Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method