Non-Invasive Diagnostic Panel for MASLD in Children With Obesity (PedMASLD-Pilot)
29. Juli 2026 aktualisiert von: Agah Bahadır Öztürk,MD, Kayseri City Hospital
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
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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease of childhood and is closely associated with obesity. Liver biopsy, the histological reference standard, is not ethically acceptable as a routine screening tool in children because it requires general anaesthesia and carries procedural risk and sampling error. The currently used non-invasive screening tools, alanine aminotransferase and ultrasonography, have limited diagnostic accuracy when used alone. An accurate, non-invasive diagnostic approach for pediatric MASLD is therefore needed.
This single-center, prospective, two-group, exploratory pilot diagnostic classification study is conducted at Kayseri City Hospital, Kayseri, Türkiye. Children aged 8 to 18 years with a body mass index at or above the 85th percentile for age and sex, according to Turkish national growth references, are screened consecutively in the pediatric endocrinology outpatient clinic. Enrollment of 180 participants is planned, balanced by sex.
Each participant attends a single study visit of approximately three hours. After a 12-hour fast, a single venous blood sample is obtained for routine biochemistry, insulin, and the serum biomarker panel; serum and plasma aliquots are stored at -80 °C until batched analysis by enzyme-linked immunosorbent assay in duplicate with blinded internal controls. Abdominal ultrasonography is performed for hepatic steatosis grading, and liver stiffness is measured by two-dimensional shear wave elastography. A separate whole-blood sample is used for DNA isolation and genotyping of three MASLD-associated variants, from which a three-variant polygenic risk score is derived. Anthropometric measurements including waist circumference percentile, blood pressure, pubertal staging, and questionnaire-based nutritional and physical activity assessment are recorded at the same visit. No therapeutic intervention is assigned by the study protocol.
Participants are classified as MASLD-positive or MASLD-negative using a composite reference standard based on ultrasonographic steatosis grading together with cardiometabolic risk factor criteria, in accordance with current pediatric guidelines. To avoid incorporation bias, two-dimensional shear wave elastography is used only as a candidate predictor and does not contribute to the reference standard; reference standard assessment is performed blinded to biomarker and genotype results.
The analysis develops a LASSO-regularized logistic regression model combining serum biomarkers, liver stiffness, and the polygenic risk score, with internal validation by bootstrap resampling. Model discrimination is compared with alanine aminotransferase alone and with ultrasonography alone. Reporting will follow the STARD 2015 statement.
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
180
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Agah Bahadır Öztürk, MD
- Telefonnummer: 05058116762 Türkiye
- E-Mail: dr-agahoz@hotmail.com
Studienorte
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Kayseri, Türkei (türkiye), 38080
- Kayseri City Hospital
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Kontakt:
- Agah B ÖZTÜRK, Principal Investigator, Department of Pediatrics, MD
- Telefonnummer: +90 352 315 77 00
- E-Mail: agahbahadir.ozturk@sbu.edu.tr
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
Akzeptiert gesunde Freiwillige
Nein
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
Children aged 8 to 18 years with a body mass index at or above the 85th percentile for age and sex, screened consecutively in the pediatric endocrinology outpatient clinic of a single tertiary center in Kayseri, Türkiye.
Participants are enrolled prospectively using consecutive non-probability sampling and are classified as MASLD-positive or MASLD-negative according to a composite reference standard.
Beschreibung
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Viral hepatitis.
- Autoimmune liver disease.
- Wilson disease, alpha-1 antitrypsin deficiency, or hereditary hemochromatosis.
- Use of hepatotoxic medication, including corticosteroids, methotrexate, valproate, amiodarone, or tamoxifen.
- Fasting duration shorter than 12 hours.
- 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.
- Total parenteral nutrition.
- Diabetic ketoacidosis.
- Inability to obtain informed consent.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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Group 1 MASLD-Positive
MASLD-Positive - Children with obesity classified as having MASLD by the composite reference standard (ultrasonographic steatosis grading plus cardiometabolic risk factor criteria).
All candidate index tests are performed.
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All participants undergo the same set of index tests at a single study visit: a fasting venous blood sample for serum 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 measured by enzyme-linked immunosorbent assay and standard laboratory methods; abdominal ultrasonography with two-dimensional shear wave elastography for liver stiffness; and genotyping of PNPLA3 rs738409, TM6SF2 rs58542926 and HSD17B13 rs72613567 for derivation of a three-variant polygenic risk score.
These are observational measurements; no therapeutic intervention is administered.
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Group 2 MASLD-Negative
MASLD-Negative - Children with obesity not meeting the composite reference standard for MASLD.
All candidate index tests are performed.
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All participants undergo the same set of index tests at a single study visit: a fasting venous blood sample for serum 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 measured by enzyme-linked immunosorbent assay and standard laboratory methods; abdominal ultrasonography with two-dimensional shear wave elastography for liver stiffness; and genotyping of PNPLA3 rs738409, TM6SF2 rs58542926 and HSD17B13 rs72613567 for derivation of a three-variant polygenic risk score.
These are observational measurements; no therapeutic intervention is administered.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Diagnostic Performance of the LASSO-Regularized Multi-Parameter Panel for MASLD
Zeitfenster: Through study completion, an average of 12 months
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Discriminative performance of a LASSO-regularized logistic regression model combining serum biomarkers (cytokeratin-18 M30, cytokeratin-18 M65, fibroblast growth factor 21, retinol-binding protein 4, insulin-like growth factor binding protein 7), homeostatic model assessment of insulin resistance, liver stiffness measured by two-dimensional shear wave elastography, and a three-variant polygenic risk score, for classifying participants against the composite reference standard for MASLD.
Metric: area under the receiver operating characteristic curve with bootstrap-derived 95% confidence interval.
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Through study completion, an average of 12 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Comparative Discrimination of the Panel Versus Alanine Aminotransferase Alone and Ultrasonography Alone
Zeitfenster: Through study completion, an average of 12 months
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Comparison of the area under the receiver operating characteristic curve of the multi-parameter panel with that of alanine aminotransferase alone and of ultrasonography alone for classification against the composite reference standard, using the DeLong test for correlated curves.
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Through study completion, an average of 12 months
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Serum Biomarker Concentrations in MASLD-Positive Versus MASLD-Negative Children With Obesity
Zeitfenster: Day 1 (single study visit)
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Comparison of serum concentrations of cytokeratin-18 M30 and M65, fibroblast growth factor 21, retinol-binding protein 4, insulin-like growth factor binding protein 7, adiponectin and leptin between participants classified as MASLD-positive and MASLD-negative.
Units of measure as reported by the respective enzyme-linked immunosorbent assays.
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Day 1 (single study visit)
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Incremental Discriminative Value of Serum IGFBP7
Zeitfenster: Through study completion, an average of 12 months
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Incremental contribution of serum insulin-like growth factor binding protein 7 to the classification model, evaluated by change in the area under the receiver operating characteristic curve, the net reclassification improvement, and the integrated discrimination improvement.
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Through study completion, an average of 12 months
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Agah B ÖZTÜRK, MD, Kayseri City Hospital, Kayseri, Türkiye
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
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Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Juli 2026
Primärer Abschluss (Geschätzt)
1. April 2027
Studienabschluss (Geschätzt)
1. Juni 2027
Studienanmeldedaten
Zuerst eingereicht
22. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
24. Juli 2026
Zuerst gepostet (Tatsächlich)
28. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
30. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
29. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Pathologische Prozesse
- Ernährungsstörungen
- Krankheitsattribute
- Stoffwechselerkrankungen
- Überernährung
- Körpergewicht
- Erkrankungen des Verdauungssystems
- Störungen des Glukosestoffwechsels
- Leberkrankheiten
- Insulinresistenz
- Hyperinsulinismus
- Übergewicht
- Fettleibigkeit
- Krankheitsanfälligkeit
- Fettleber
- Genetische Veranlagung für Krankheiten
- Pathologische Zustände, Anzeichen und Symptome
- Ernährungs- und Stoffwechselerkrankungen
- Anzeichen und Symptome
- Genetischer Risiko-Score
- Metabolisches Syndrom
- Nicht alkoholische Fettleber
- Adipositas bei Kindern
Andere Studien-ID-Nummern
- Etik C.D.No:1009(Kayseri CH)
- TUSEB-2026-A4-U-55859 (Andere Kennung: Health Institutes of Türkiye (TÜSEB))
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
De-identified individual participant data underlying the published results, including serum biomarker concentrations, anthropometric, clinical and laboratory variables, and derived index values, will be available from the principal investigator upon reasonable request.
Individual genotype data will be shared only in aggregate or as derived polygenic risk scores, in accordance with the ethics approval and applicable data protection legislation.
Data will be shared with qualified researchers whose proposed use has been approved and is consistent with the original ethics approval.
A data-use agreement will be required.
IPD-Sharing-Zeitrahmen
Data will become available after publication of the main results and will remain available for 5 years thereafter, upon reasonable request to the principal investigator
IPD-Sharing-Zugriffskriterien
Qualified researchers may request access by contacting the principal investigator.
Requests will be evaluated for scientific merit and for consistency with the original ethics approval and the scope of participant consent.
A data-use agreement must be executed before de-identified data are released.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .