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Identification of clinically relevant biomarkers for early detection of progression analysis of NAFLD to NASH

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/12/060718
Enrollment
1000
Registered
2023-12-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K740- Hepatic fibrosis

Interventions

Intervention1: NIL: NIL

Sponsors

Strand Life Sciences Private Limited
Lead Sponsor

Eligibility

Inclusion 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 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The primary outcome of the study will aid in the identification of diagnostic markers that enable early detection of NASH and the understanding of the genomic markup of NASH variations predisposing to or protecting from the disease. In addition, the study can also aid in the identification of targets for drug development for the disease.Timepoint: At Baseline—

Secondary

MeasureTime frame
Not availableTimepoint: Not available—

Countries

India

Contacts

Public ContactDr Vamsi Veeramachaneni

Strand Life Sciences Private Limited

vamsi@strandls.com08023095200

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026