Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07433205
Eligibility Criteria:
Inclusion Criteria:
Age 20 to 90 years at enrollment. Able and willing to provide written informed consent. Willing and able to comply with study assessments and follow-up for up to 2 years.
Availability of baseline clinical evaluation and laboratory tests required by the protocol.
For the MASLD cohort: Evidence of hepatic steatosis at baseline (e.g., imaging and/or noninvasive assessment) in the presence of metabolic dysfunction, consistent with contemporary MASLD criteria, and without alternative causes of steatosis per protocol.
For the Control cohort: No evidence of MASLD/ hepatic steatosis at baseline (based on available imaging and/or noninvasive assessment), recruited from the same source population.
Exclusion Criteria:
Significant alcohol consumption exceeding protocol-defined thresholds. Known chronic liver diseases other than MASLD (including but not limited to chronic hepatitis B or C, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's disease, hemochromatosis, or alpha-1 antitrypsin deficiency).
History of hepatocellular carcinoma, liver transplantation, or other active malignancy (except adequately treated non-melanoma skin cancer or carcinoma in situ) that may interfere with follow-up.
Decompensated liver disease at baseline (e.g., ascites, variceal bleeding, hepatic encephalopathy) if not intended to be included per protocol.
Use of medications known to cause hepatic steatosis or steatohepatitis (e.g., amiodarone, methotrexate, systemic corticosteroids, tamoxifen) within a protocol-defined period, if judged to be the primary cause of steatosis.
Pregnancy or breastfeeding at enrollment (if applicable to your protocol assessments).
Any serious medical condition or psychiatric disorder that, in the investigator's opinion, would make participation unsafe or interfere with study assessments or follow-up.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
90 Years
Study:
NCT07433205
Study Brief:
Protocol Section:
NCT07433205