NCT07731360Not yet recruiting
Non-Invasive Diagnostic Panel for MASLD in Children With Obesity
A Non-Invasive Diagnostic Panel for MASLD in Children With Obesity: Evaluation of a Multiparametric Biomarker Panel and Genetic Risk Score Using LASSO-Regularized Logistic Regression - The PedMASLD-MultiOmics Pilot Study
Source: ClinicalTrials.gov · Last updated 30 Jul 2026
Brief summary (registry, in English)
This prospective, single-center, two-group observational study evaluates a non-invasive multi-parameter diagnostic panel for metabolic dysfunction-associated steatotic liver disease (MASLD) in children with obesity. A total of 180 children aged 8 to 18 years with a body mass index at or above the 85th percentile for age and sex are planned for enrollment at a single tertiary pediatric center. Each participant attends a single study visit comprising a fasting venous blood sample for serum biomarkers (cytokeratin-18 M30 and M65, fibroblast growth factor 21, retinol-binding protein 4, insulin-like growth factor binding protein 7, adiponectin, leptin, insulin, and routine biochemistry), abdominal ultrasonography with two-dimensional shear wave elastography, and genotyping of three MASLD-associated variants (PNPLA3 rs738409, TM6SF2 rs58542926, HSD17B13 rs72613567). Participants are classified as MASLD-positive or MASLD-negative according to a guideline-based composite reference standard consisting of ultrasonographic steatosis grading and cardiometabolic risk factor criteria, assessed independently of the candidate index tests. The primary objective is to determine the discriminative performance, expressed as the area under the receiver operating characteristic curve, of a LASSO-regularized logistic regression model combining biomarker, elastography, and genetic predictors. No therapeutic intervention is assigned by the study protocol. Reporting will follow the STARD 2015 statement.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 180 (estimated)
- First submitted
- 22 Jul 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Kayseri City Hospital
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07731360
What you commit to
- Study type: Observational
- Planned participants: 180
- From 1 Jul 2026 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of hepatotoxic medication, including corticosteroids, methotrexate, valproate, amiodarone, or tamoxifen.
Other illness
- Viral hepatitis.
- Autoimmune liver disease.
- Wilson disease, alpha-1 antitrypsin deficiency, or hereditary hemochromatosis.
- Active infection, defined as C-reactive protein above 10 mg/L.
- Untreated thyroid disorder, defined as thyroid-stimulating hormone below 0.5 or above 5.
Other
- Fasting duration shorter than 12 hours.
- Total parenteral nutrition.
- Diabetic ketoacidosis.
- Inability to obtain informed consent.
Who the study is looking for
- Age 8 to 18 years.
- Body mass index at or above the 85th percentile for age and sex according to Turkish national growth references.
- Hepatic steatosis of grade 1 or higher on abdominal ultrasonography and/or alanine aminotransferase at or above the biology-based upper limit of normal (26 U/L for boys; 22 U/L for girls), or persistent alanine aminotransferase elevation at or above twice the upper limit of normal (50 U/L for boys; 44 U/L for girls).
- At least one cardiometabolic risk factor.
- Written informed consent provided by a parent or legal guardian, with simplified assent for children aged 8 to 11 years and standard assent for children aged 12 years and older.
Age in the registry: 8 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kayseri City Hospital Coordinator of this site? Confirm its status | Kayseri | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.