Biomarker Panel for PCOS-Associated Liver Steatosis in Adolescent Girls (COMPASS-pedPCOS) (COMPASSpedPCOS)
2026년 7월 29일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
관찰
등록 (추정된)
150
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Agah B Öztürk, MD, MD
- 전화번호: +90 352 315 77 00
- 이메일: dr-agahoz@hotmail.com
연구 장소
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Kayseri, 터키 (Türkiye), 38080
- University of Health Sciences, Kayseri City Hospital
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연락하다:
- Agah B ÖZTÜRK, Principal Investigator, Department of Pediatrics, MD
- 전화번호: +90 352 315 77 00
- 이메일: agahbahadir.ozturk@sbu.edu.tr
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
예
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hepatic Steatosis Measured by Controlled Attenuation Parameter (CAP)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Serum Soluble CD163 Concentration
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Serum Growth Differentiation Factor 15 (GDF-15) Concentration
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Agah B ÖZTÜRK, MD, Kayseri City Hospital, Kayseri, Türkiye
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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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- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2027년 4월 30일
연구 완료 (추정된)
2027년 9월 1일
연구 등록 날짜
최초 제출
2026년 7월 22일
QC 기준을 충족하는 최초 제출
2026년 7월 24일
처음 게시됨 (실제)
2026년 7월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 29일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
- 비뇨생식기 질환
- 생식기 질환
- 내분비계 질환
- 영양 장애
- 신생물
- 남성 비뇨 생식기 질환
- 여성 비뇨 생식기 질환
- 여성 비뇨 생식기 질환 및 임신 합병증
- 대사 질환
- 영양 과잉
- 체중
- 소화기계 질환
- 생식기 질환, 여성
- 포도당 대사 장애
- 간 질환
- 난소 질환
- 부속기 질환
- 생식선 장애
- 선천적 이상
- 인슐린 저항성
- 고인슐린증
- 초과 중량
- 난소 낭종
- 낭종
- 성 발달 장애
- 비뇨 생식기 이상
- 비만
- 46, XX 성 발달 장애
- 부신생식기 증후군
- 선천성, 유전성, 신생아 질환 및 이상
- 병리학적 상태, 징후 및 증상
- 영양 및 대사 질환
- 징후 및 증상
- 대사 증후군
- 다낭성 난소 증후군
- 지방간
- 소아 비만
- 안드로겐 과다증
기타 연구 ID 번호
- Etik C.D.No:1010 (Kayseri CH)
- TÜSEB2026-A4-U ProjectNo55983 (기타 식별자: Health Institutes of Türkiye (TÜSEB))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
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 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .