Not Yet RecruitingNot Applicable

Biomarker Panel for PCOS-Associated Liver Steatosis in Adolescent Girls (COMPASS-pedPCOS)

Turkey (Türkiye)150 participantsStarted 2026-09-01

Plain-language summary

This single-center, prospective, observational, cross-sectional mechanistic pilot study will evaluate whether polycystic ovary syndrome (PCOS) contributes to hepatic steatosis in adolescent girls independently of adiposity. A total of 150 girls aged 10-18 years will be enrolled into three groups of 50: girls with PCOS and obesity, age- and body mass index-matched girls with obesity but without PCOS, and healthy normal-weight girls. Each participant will undergo a single evaluation comprising anthropometry, clinical and biochemical phenotyping, transient elastography with controlled attenuation parameter and two-dimensional shear wave elastography, and a single venous blood sample. An extended biomarker panel will be measured by enzyme-linked immunosorbent assay (Fetuin-A, fibroblast growth factor 21, adiponectin, visfatin, cytokeratin-18 M30 and M65, soluble CD163, growth differentiation factor 15, 11-ketotestosterone, and 11beta-hydroxyandrostenedione), together with liquid chromatography-tandem mass spectrometry measurement of testosterone and sex hormone-binding globulin, and genotyping of PNPLA3 rs738409 and HSD17B13 rs72613567. The primary objective is to compare hepatic steatosis and the hepatokine/adipokine profile between the PCOS with obesity group and the adiposity-matched obesity control group, adjusting for body mass index z-score, insulin resistance, and free androgen index. No therapeutic intervention is assigned by the study protocol.

Who can participate

Age range

10 Years – 18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female, aged 10 to 18 years, with written informed consent from a parent or legal guardian and written assent from the child. * Group 1 (PCOS with obesity): both hyperandrogenism and oligo-anovulation required, based on adolescent-adapted Rotterdam criteria; body mass index at or above the 95th percentile. * Group 2 (Obesity control): body mass index at or above the 95th percentile, without features of PCOS, matched to Group 1 for age and body mass index. * Group 3 (Healthy control): healthy normal-weight girls (body mass index between the 5th and 84th percentile) without chronic disease, hyperandrogenism, or menstrual irregularity. Exclusion Criteria: * Known acute or chronic liver disease (including viral, autoimmune, or Wilson disease) or use of hepatotoxic medication. * Endocrine disorders or secondary hyperandrogenism, including Cushing syndrome, hypothyroidism, uncontrolled diabetes mellitus, congenital adrenal hyperplasia, androgen-secreting tumour, or hyperprolactinaemia. * Syndromic or monogenic obesity (including Prader-Willi syndrome, Bardet-Biedl syndrome, Alström syndrome, MC4R or LEP variants) or a known genetic disorder. * Use of relevant or hepatotoxic medication within the preceding three months, including corticosteroids, metformin, oral contraceptives, valproic acid, or antiandrogens. * Pregnancy or regular alcohol use. * Refusal of consent or assent.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is looking at biomarkers like Fetuin-A, FGF-21, and adiponectin to detect liver fat in adolescent girls with PCOS — since it's a biomarker study and not testing a treatment, what would my daughter actually gain from participating, and how might the results affect her care?
2The trial is listed as 'not yet recruiting' — do you know when it's expected to open, and is there anything we should be doing right now to monitor her liver health while we wait?
3Since one of the key measurements is a CAP ultrasound scan to assess liver fat, is that something my daughter should be getting as part of her regular PCOS follow-up regardless of whether she joins this trial?
4This study focuses on adolescent girls with PCOS alongside things like insulin resistance and obesity — based on my daughter's specific situation, do you think she would even be a candidate worth discussing with the research team once enrollment opens?
5If this trial is purely observational and not offering a new treatment, are there existing clinical pathways or other studies we should consider that might more directly address her liver or metabolic concerns in the meantime?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hepatic Steatosis Measured by Controlled Attenuation Parameter (CAP)

Timeframe: Day 1 (single study visit)

Serum Fetuin-A Concentration

Timeframe: Day 1 (single study visit)

Serum Fibroblast Growth Factor 21 (FGF-21) Concentration

Timeframe: Day 1 (single study visit)

Serum Adiponectin Concentration

Timeframe: Day 1 (single study visit)

Serum Visfatin Concentration

Timeframe: Day 1 (single study visit)

Trial details

NCT IDNCT07731373

SponsorKayseri City Hospital

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2027-04-30

Contact for this trial

Agah B Öztürk, MD, MD

+90 352 315 77 00 dr-agahoz@hotmail.com

View on ClinicalTrials.gov More Polycystic Ovary Syndrome (PCOS) trials

Plain-language summary

Who can participate

Age range

10 Years – 18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Hepatic Steatosis Measured by Controlled Attenuation Parameter (CAP)

Timeframe: Day 1 (single study visit)

Serum Fetuin-A Concentration

Timeframe: Day 1 (single study visit)

Serum Fibroblast Growth Factor 21 (FGF-21) Concentration

Timeframe: Day 1 (single study visit)

Serum Adiponectin Concentration

Timeframe: Day 1 (single study visit)

Serum Visfatin Concentration

Timeframe: Day 1 (single study visit)