Biomarker Panel for PCOS-Associated Liver Steatosis in Adolescent Girls (COMPASS-pedPCOS) (COMPASSpedPCOS)
2026年7月29日 更新者：Agah Bahadır Öztürk,MD、Kayseri City Hospital
COMPASS-PedPCOS: BMI-Independent Mechanistic Dissection of PCOS-Associated MASLD in Adolescent Girls With Obesity Using an Expanded Biomarker Panel - A Single-Center Pre-Pilot Clinical Study
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.
調査の概要
状態
状態
まだ募集していません
条件
条件
介入・治療
介入・治療
詳細な説明
Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver condition of childhood and is closely linked to obesity and insulin resistance. Polycystic ovary syndrome (PCOS) frequently co-occurs with obesity in adolescent girls, and hyperandrogenism has been proposed as an additional hepatic insult. Because obesity is a powerful confounder, the independent contribution of hyperandrogenism to hepatic steatosis in adolescents remains poorly defined.
This study will be conducted at the Departments of Pediatric, Departments of Pediatric Endocrinology, Pediatric Gastroenterology and Hepatology, Medical Biochemistry, Medical Genetics, and Pediatric Radiology of Kayseri City Hospital, Kayseri, Türkiye. Participants will be allocated to three predefined groups. Group 1 comprises girls with PCOS and obesity, diagnosed according to adolescent-adapted Rotterdam criteria requiring both hyperandrogenism and oligo-anovulation, with a body mass index at or above the 95th percentile. Group 2 comprises girls with obesity without features of PCOS, matched to Group 1 for age and body mass index. Group 3 comprises healthy normal-weight girls between the 5th and 84th body mass index percentiles.
The central comparison is Group 1 versus Group 2, which equalises adiposity and therefore isolates the contribution of hyperandrogenism. Hierarchical regression models will additionally adjust for body mass index z-score, homeostatic model assessment of insulin resistance, and free androgen index. Hepatic steatosis will be quantified by the controlled attenuation parameter obtained during vibration-controlled transient elastography; liver stiffness will be assessed by vibration-controlled transient elastography and two-dimensional shear wave elastography.
A single venous blood sample will be obtained at the study visit. Serum will be separated and stored at minus 80 degrees Celsius until batch analysis, and genomic DNA will be isolated for TaqMan single nucleotide polymorphism genotyping of PNPLA3 rs738409 and HSD17B13 rs72613567. All enzyme-linked immunosorbent assay kits will be procured as a single lot, and intra-assay and inter-assay coefficients of variation together with spike-recovery validation will be documented for each kit.
Data will be recorded in a REDCap electronic case report form in accordance with ALCOA+ principles. The study is exploratory and is designed to generate effect-size and variance estimates for a subsequent validation study. Reporting will follow the STROBE statement, and non-invasive diagnostic performance analyses will follow the STARD 2015 statement. The study is also referred to as COMPASS-PedPCOS in institutional, ethics committee and funding documents.
研究の種類
研究の種類
観察的
入学 (推定)
入学
150
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
研究連絡先
- 名前：Agah B Öztürk, MD, MD
- 電話番号：+90 352 315 77 00
- メール：dr-agahoz@hotmail.com
研究場所
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-
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Kayseri、トルコ（Türkiye）、38080
- University of Health Sciences, Kayseri City Hospital
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コンタクト：
- Agah B ÖZTÜRK, Principal Investigator, Department of Pediatrics, MD
- 電話番号：+90 352 315 77 00
- メール：agahbahadir.ozturk@sbu.edu.tr
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
はい
サンプリング方法
非確率サンプル
調査対象母集団
Adolescent girls aged 10 to 18 years presenting to the Departments of Pediatric Endocrinology and Pediatric Gastroenterology and Hepatology of Kayseri City Hospital, Kayseri, Türkiye.
The study population comprises girls with polycystic ovary syndrome and obesity, girls with obesity without polycystic ovary syndrome matched for age and body mass index, and healthy normal-weight girls.
Participants will be enrolled prospectively by consecutive sampling of eligible admissions.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
グループ/コホートの数
3
コホートと介入
グループ/コホートグループ/コホート |
介入・治療介入・治療 |
|---|---|
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Group 1 ''PCOS With Obesity''
PCOS With Obesity (n=50) - Girls aged 10-18 years meeting adolescent-adapted Rotterdam criteria (both hyperandrogenism and oligo-anovulation required) with body mass index at or above the 95th percentile.
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A single fasting venous blood sample is obtained at the study visit.
Enzyme-linked immunosorbent assay measurement of Fetuin-A, fibroblast growth factor 21, adiponectin, visfatin, cytokeratin-18 M30, cytokeratin-18 M65, soluble CD163, growth differentiation factor 15, 11-ketotestosterone and 11beta-hydroxyandrostenedione is performed.
Total testosterone and sex hormone-binding globulin are measured by liquid chromatography-tandem mass spectrometry.
Routine biochemistry and hormonal profiling are performed from the same sample.
Observational only; no therapeutic agent is administered.
Hepatic steatosis and liver stiffness are assessed non-invasively at the same study visit.
Vibration-controlled transient elastography with controlled attenuation parameter yields attenuation (dB/m) and stiffness (kPa) values; two-dimensional shear wave elastography provides an independent stiffness estimate.
Predefined validity criteria are applied to all acquisitions.
No sedation, contrast agent or ionizing radiation is used; the procedure is observational.
Genomic DNA is isolated from the same single venous blood sample; no additional venipuncture is required.
TaqMan allelic discrimination assays are used for genotyping of PNPLA3 rs738409 and HSD17B13 rs72613567.
Genotype call rate and Hardy-Weinberg equilibrium are reported.
Genotyping is performed for research purposes only; results are not used to guide clinical management.
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Group 2 ''Obesity Control''
Obesity Control (n=50) - Girls with body mass index at or above the 95th percentile without features of PCOS, matched to Group 1 for age and body mass index.
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A single fasting venous blood sample is obtained at the study visit.
Enzyme-linked immunosorbent assay measurement of Fetuin-A, fibroblast growth factor 21, adiponectin, visfatin, cytokeratin-18 M30, cytokeratin-18 M65, soluble CD163, growth differentiation factor 15, 11-ketotestosterone and 11beta-hydroxyandrostenedione is performed.
Total testosterone and sex hormone-binding globulin are measured by liquid chromatography-tandem mass spectrometry.
Routine biochemistry and hormonal profiling are performed from the same sample.
Observational only; no therapeutic agent is administered.
Hepatic steatosis and liver stiffness are assessed non-invasively at the same study visit.
Vibration-controlled transient elastography with controlled attenuation parameter yields attenuation (dB/m) and stiffness (kPa) values; two-dimensional shear wave elastography provides an independent stiffness estimate.
Predefined validity criteria are applied to all acquisitions.
No sedation, contrast agent or ionizing radiation is used; the procedure is observational.
Genomic DNA is isolated from the same single venous blood sample; no additional venipuncture is required.
TaqMan allelic discrimination assays are used for genotyping of PNPLA3 rs738409 and HSD17B13 rs72613567.
Genotype call rate and Hardy-Weinberg equilibrium are reported.
Genotyping is performed for research purposes only; results are not used to guide clinical management.
|
|
Group 3 ''Healthy Control''
Healthy Control (n=50) - Girls aged 10-18 years meeting adolescent, Healthy normal-weight girls (body mass index 5th-84th percentile) without chronic disease, hyperandrogenism, or menstrual irregularity.
|
A single fasting venous blood sample is obtained at the study visit.
Enzyme-linked immunosorbent assay measurement of Fetuin-A, fibroblast growth factor 21, adiponectin, visfatin, cytokeratin-18 M30, cytokeratin-18 M65, soluble CD163, growth differentiation factor 15, 11-ketotestosterone and 11beta-hydroxyandrostenedione is performed.
Total testosterone and sex hormone-binding globulin are measured by liquid chromatography-tandem mass spectrometry.
Routine biochemistry and hormonal profiling are performed from the same sample.
Observational only; no therapeutic agent is administered.
Hepatic steatosis and liver stiffness are assessed non-invasively at the same study visit.
Vibration-controlled transient elastography with controlled attenuation parameter yields attenuation (dB/m) and stiffness (kPa) values; two-dimensional shear wave elastography provides an independent stiffness estimate.
Predefined validity criteria are applied to all acquisitions.
No sedation, contrast agent or ionizing radiation is used; the procedure is observational.
Genomic DNA is isolated from the same single venous blood sample; no additional venipuncture is required.
TaqMan allelic discrimination assays are used for genotyping of PNPLA3 rs738409 and HSD17B13 rs72613567.
Genotype call rate and Hardy-Weinberg equilibrium are reported.
Genotyping is performed for research purposes only; results are not used to guide clinical management.
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Hepatic Steatosis Measured by Controlled Attenuation Parameter (CAP)
時間枠：Day 1 (single study visit)
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Controlled attenuation parameter obtained during vibration-controlled transient elastography, compared between girls with PCOS and obesity and adiposity-matched girls with obesity, and across all three study groups, with adjustment for body mass index z-score, homeostatic model assessment of insulin resistance, and free androgen index.
Unit of measure: dB/m.
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Day 1 (single study visit)
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Serum Fetuin-A Concentration
時間枠：Day 1 (single study visit)
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Serum Fetuin-A measured by enzyme-linked immunosorbent assay and compared across the three study groups with adjustment for body mass index z-score, homeostatic model assessment of insulin resistance, and free androgen index.
Unit of measure: µg/mL.
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Day 1 (single study visit)
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Serum Fibroblast Growth Factor 21 (FGF-21) Concentration
時間枠：Day 1 (single study visit)
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Serum FGF-21 measured by enzyme-linked immunosorbent assay and compared across the three study groups with adjustment for body mass index z-score, homeostatic model assessment of insulin resistance, and free androgen index.
Unit of measure: pg/mL.
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Day 1 (single study visit)
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Serum Adiponectin Concentration
時間枠：Day 1 (single study visit)
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Serum adiponectin measured by enzyme-linked immunosorbent assay and compared across the three study groups with adjustment for body mass index z-score, homeostatic model assessment of insulin resistance, and free androgen index.
Unit of measure: µg/mL.
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Day 1 (single study visit)
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Serum Visfatin Concentration
時間枠：Day 1 (single study visit)
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Serum visfatin measured by enzyme-linked immunosorbent assay and compared across the three study groups with adjustment for body mass index z-score, homeostatic model assessment of insulin resistance, and free androgen index.
Unit of measure: ng/mL.
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Day 1 (single study visit)
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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Serum Soluble CD163 Concentration
時間枠：Day 1 (single study visit)
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Serum soluble CD163, a marker of macrophage activation, measured by enzyme-linked immunosorbent assay and compared across the three study groups; evaluated as a candidate mediator of the association between hyperandrogenism and hepatic steatosis.
Unit of measure: ng/mL.
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Day 1 (single study visit)
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Serum Cytokeratin-18 M30 and M65 Concentrations
時間枠：Day 1 (single study visit)
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Serum cytokeratin-18 M30 (apoptotic fragment) and M65 (total cell death) measured by enzyme-linked immunosorbent assay and compared across the three study groups to characterise the mode of hepatocyte death.
Unit of measure: U/L for each analyte.
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Day 1 (single study visit)
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Liver Stiffness Measurement
時間枠：Day 1 (single study visit)
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Liver stiffness assessed by vibration-controlled transient elastography and by two-dimensional shear wave elastography, compared across the three study groups.
Unit of measure: kPa.
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Day 1 (single study visit)
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Discriminatory Performance of the Biomarker Panel for Hepatic Steatosis
時間枠：Day 1 (single study visit)
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Receiver operating characteristic analysis of individual biomarkers and of a composite preliminary risk score for the identification of hepatic steatosis.
Measures include area under the receiver operating characteristic curve with 95% confidence intervals, sensitivity, and specificity at the Youden index.
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Day 1 (single study visit)
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その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Serum Growth Differentiation Factor 15 (GDF-15) Concentration
時間枠：Day 1 (single study visit)
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Serum GDF-15, a marker of mitochondrial stress, measured by enzyme-linked immunosorbent assay and compared across the three study groups.
Unit of measure: pg/mL.
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Day 1 (single study visit)
|
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Serum 11-Oxygenated Androgen Concentrations
時間枠：Day 1 (single study visit)
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Serum 11-ketotestosterone and 11beta-hydroxyandrostenedione measured by enzyme-linked immunosorbent assay and evaluated for association with hepatic steatosis measures independently of body mass index and insulin resistance.
Unit of measure: ng/dL for each analyte.
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Day 1 (single study visit)
|
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PNPLA3 rs738409 and HSD17B13 rs72613567 Genotype Distribution and Gene-Gene Interaction
時間枠：Day 1 (single study visit)
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Genotype frequencies of PNPLA3 rs738409 and HSD17B13 rs72613567 determined by TaqMan assay, and evaluation of gene-gene interaction with respect to hepatic steatosis measures.
Measure: genotype counts and interaction estimates; Hardy-Weinberg equilibrium will be assessed.
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Day 1 (single study visit)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
協力者
捜査官
捜査官
- 主任研究者：Agah B ÖZTÜRK, MD、Kayseri City Hospital, Kayseri, Türkiye
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, Lijmer JG, Moher D, Rennie D, de Vet HC, Kressel HY, Rifai N, Golub RM, Altman DG, Hooft L, Korevaar DA, Cohen JF; STARD Group. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015 Oct 28;351:h5527. doi: 10.1136/bmj.h5527.
- von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7. doi: 10.1016/S0140-6736(07)61602-X.
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
研究開始
2026年9月1日
一次修了 (推定)
一次修了
2027年4月30日
研究の完了 (推定)
研究の完了
2027年9月1日
試験登録日
最初に提出
最初に提出
2026年7月22日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2026年7月24日
最初の投稿 (実際)
最初の投稿
2026年7月28日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2026年7月30日
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
2026年7月29日
最終確認日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- Etik C.D.No:1010 (Kayseri CH)
- TÜSEB2026-A4-U ProjectNo55983 (その他の識別子：Health Institutes of Türkiye (TÜSEB))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
De-identified individual participant data underlying the published results, including clinical, anthropometric, biochemical, biomarker, and imaging variables, will be available from the principal investigator upon reasonable request.
Individual-level genotype data will be shared only in aggregate form, or in de-identified individual-level form where explicitly permitted by the participant consent and the ethics approval, in accordance with applicable national legislation on special categories of personal data.
Requests will be evaluated for scientific merit and consistency with the original ethics approval, and a data-use agreement will be required.
IPD 共有時間枠
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 共有アクセス基準
Qualified researchers from recognised academic institutions may request access by contacting the principal investigator with a methodologically sound proposal.
Requests will be reviewed by the study team for scientific merit and for consistency with the original ethics approval and participant consent.
A signed data-use agreement is required before any de-identified data are released.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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