Biomarker Panel for PCOS-Associated Liver Steatosis in Adolescent Girls (COMPASS-pedPCOS) (COMPASSpedPCOS)
29 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Estimé)
150
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Agah B Öztürk, MD, MD
- Numéro de téléphone: +90 352 315 77 00
- E-mail: dr-agahoz@hotmail.com
Lieux d'étude
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Kayseri, Turquie (Türkiye), 38080
- University of Health Sciences, Kayseri City Hospital
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Contact:
- Agah B ÖZTÜRK, Principal Investigator, Department of Pediatrics, MD
- Numéro de téléphone: +90 352 315 77 00
- E-mail: agahbahadir.ozturk@sbu.edu.tr
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
Oui
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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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.
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|
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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Hepatic Steatosis Measured by Controlled Attenuation Parameter (CAP)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Serum Soluble CD163 Concentration
Délai: Day 1 (single study visit)
|
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
Délai: 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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Serum Growth Differentiation Factor 15 (GDF-15) Concentration
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Agah B ÖZTÜRK, MD, Kayseri City Hospital, Kayseri, Türkiye
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
- Peduzzi P, Concato J, Kemper E, Holford TR, Feinstein AR. A simulation study of the number of events per variable in logistic regression analysis. J Clin Epidemiol. 1996 Dec;49(12):1373-9. doi: 10.1016/s0895-4356(96)00236-3.
- Abul-Husn NS, Cheng X, Li AH, Xin Y, Schurmann C, Stevis P, Liu Y, Kozlitina J, Stender S, Wood GC, Stepanchick AN, Still MD, McCarthy S, O'Dushlaine C, Packer JS, Balasubramanian S, Gosalia N, Esopi D, Kim SY, Mukherjee S, Lopez AE, Fuller ED, Penn J, Chu X, Luo JZ, Mirshahi UL, Carey DJ, Still CD, Feldman MD, Small A, Damrauer SM, Rader DJ, Zambrowicz B, Olson W, Murphy AJ, Borecki IB, Shuldiner AR, Reid JG, Overton JD, Yancopoulos GD, Hobbs HH, Cohen JC, Gottesman O, Teslovich TM, Baras A, Mirshahi T, Gromada J, Dewey FE. A Protein-Truncating HSD17B13 Variant and Protection from Chronic Liver Disease. N Engl J Med. 2018 Mar 22;378(12):1096-1106. doi: 10.1056/NEJMoa1712191.
- Romeo S, Kozlitina J, Xing C, Pertsemlidis A, Cox D, Pennacchio LA, Boerwinkle E, Cohen JC, Hobbs HH. Genetic variation in PNPLA3 confers susceptibility to nonalcoholic fatty liver disease. Nat Genet. 2008 Dec;40(12):1461-5. doi: 10.1038/ng.257. Epub 2008 Sep 25.
- Rinella ME, Lazarus JV, Ratziu V, Francque SM, Sanyal AJ, Kanwal F, Romero D, Abdelmalek MF, Anstee QM, Arab JP, Arrese M, Bataller R, Beuers U, Boursier J, Bugianesi E, Byrne CD, Castro Narro GE, Chowdhury A, Cortez-Pinto H, Cryer DR, Cusi K, El-Kassas M, Klein S, Eskridge W, Fan J, Gawrieh S, Guy CD, Harrison SA, Kim SU, Koot BG, Korenjak M, Kowdley KV, Lacaille F, Loomba R, Mitchell-Thain R, Morgan TR, Powell EE, Roden M, Romero-Gomez M, Silva M, Singh SP, Sookoian SC, Spearman CW, Tiniakos D, Valenti L, Vos MB, Wong VW, Xanthakos S, Yilmaz Y, Younossi Z, Hobbs A, Villota-Rivas M, Newsome PN; NAFLD Nomenclature consensus group. A multisociety Delphi consensus statement on new fatty liver disease nomenclature. J Hepatol. 2023 Dec;79(6):1542-1556. doi: 10.1016/j.jhep.2023.06.003. Epub 2023 Jun 24.
- Vos MB, Barve S, Joshi-Barve S, Carew JD, Whitington PF, McClain CJ. Cytokeratin 18, a marker of cell death, is increased in children with suspected nonalcoholic fatty liver disease. J Pediatr Gastroenterol Nutr. 2008 Oct;47(4):481-5. doi: 10.1097/MPG.0b013e31817e2bfb.
- O'Reilly MW, Kempegowda P, Jenkinson C, Taylor AE, Quanson JL, Storbeck KH, Arlt W. 11-Oxygenated C19 Steroids Are the Predominant Androgens in Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2017 Mar 1;102(3):840-848. doi: 10.1210/jc.2016-3285.
- Salva-Pastor N, Chavez-Tapia NC, Uribe M, Nuno-Lambarri N. Understanding the association of polycystic ovary syndrome and non-alcoholic fatty liver disease. J Steroid Biochem Mol Biol. 2019 Nov;194:105445. doi: 10.1016/j.jsbmb.2019.105445. Epub 2019 Aug 2.
- Pena AS, Witchel SF, Boivin J, Burgert TS, Ee C, Hoeger KM, Lujan ME, Mousa A, Oberfield S, Tay CT, Teede H. International evidence-based recommendations for polycystic ovary syndrome in adolescents. BMC Med. 2025 Mar 11;23(1):151. doi: 10.1186/s12916-025-03901-w.
- Teede HJ, Tay CT, Laven JJE, Dokras A, Moran LJ, Piltonen TT, Costello MF, Boivin J, Redman LM, Boyle JA, Norman RJ, Mousa A, Joham AE; International PCOS Network. Recommendations from the 2023 international evidence-based guideline for the assessment and management of polycystic ovary syndrome. Eur J Endocrinol. 2023 Aug 2;189(2):G43-G64. doi: 10.1093/ejendo/lvad096.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
30 avril 2027
Achèvement de l'étude (Estimé)
1 septembre 2027
Dates d'inscription aux études
Première soumission
22 juillet 2026
Première soumission répondant aux critères de contrôle qualité
24 juillet 2026
Première publication (Réel)
28 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
30 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- Maladies du système endocrinien
- Troubles nutritionnels
- Tumeurs
- Maladies urogénitales masculines
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Maladies métaboliques
- Suralimentation
- Poids
- Maladies du système digestif
- Maladies génitales, femme
- Troubles du métabolisme du glucose
- Maladies du foie
- Maladies ovariennes
- Maladies annexielles
- Troubles gonadiques
- Anomalies congénitales
- Résistance à l'insuline
- Hyperinsulinisme
- En surpoids
- Kystes de l'ovaire
- Kystes
- Troubles du développement sexuel
- Anomalies urogénitales
- Obésité
- 46, XX Troubles du développement sexuel
- Syndrome surrénogénital
- Maladies et anomalies congénitales, héréditaires et néonatales
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Signes et symptômes
- Syndrome métabolique
- Syndrome des ovaires polykystiques
- Foie gras
- Obésité pédiatrique
- Hyperandrogénie
Autres numéros d'identification d'étude
- Etik C.D.No:1010 (Kayseri CH)
- TÜSEB2026-A4-U ProjectNo55983 (Autre identifiant: Health Institutes of Türkiye (TÜSEB))
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
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.
Délai de partage IPD
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.
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .