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Clinical Trials/CTRI/2023/12/060718
CTRI/2023/12/060718
Not yet recruiting
未知

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

Strand Life Sciences Private Limited0 sites0 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Strand Life Sciences Private Limited
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Not specified

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