- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04152746
Hladiny periostinu u dětí s hypertrofií adenoidů
This prospective observational study evaluated serum and tissue periostin levels in children with adenoid hypertrophy. Children with grade 3-4 adenoid hypertrophy who were scheduled for adenoidectomy were compared with children with grade 1 adenoid hypertrophy without symptoms attributable to adenoid enlargement. Serum periostin levels were compared between the two groups. In the adenoidectomy group, periostin levels in adenoid tissue were also compared with paired samples of normal nasopharyngeal mucosa obtained from the same patients. The study aimed to investigate whether periostin may be associated with the development of adenoid hypertrophy and to explore its potential role in local tissue remodeling.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Adenoid hypertrophy (AH) is a common condition in children and may result in nasal obstruction, mouth breathing, sleep-disordered breathing, recurrent upper respiratory symptoms, and other related clinical manifestations. Although allergic inflammation has been proposed as one of the mechanisms contributing to adenoid hypertrophy, the pathophysiological mechanisms underlying tissue enlargement are multifactorial and remain incompletely understood. Periostin is a matricellular protein involved in extracellular matrix organization and tissue remodeling and has been associated with inflammatory and remodeling processes in several airway diseases. However, limited information is available regarding the role of periostin in adenoid hypertrophy.
This prospective observational study was designed to investigate serum and local tissue periostin levels in children with adenoid hypertrophy. The study included children aged 2-8 years who were evaluated for adenoid hypertrophy. The adenoid hypertrophy group consisted of children with grade 3-4 adenoid hypertrophy who were scheduled for adenoidectomy based on their clinical condition. The control group consisted of children with grade 1 adenoid hypertrophy (0-25% nasopharyngeal obstruction) who had no symptoms attributable to adenoid enlargement.
Serum periostin levels were measured in both groups and compared between children with grade 3-4 and grade 1 adenoid hypertrophy. In children undergoing adenoidectomy, adenoid tissue samples were obtained during the clinically indicated surgical procedure. Paired samples of normal nasopharyngeal mucosa were also obtained from the posterior pharyngeal wall of the same patients. Periostin concentrations in adenoid tissue and paired normal nasopharyngeal mucosa were measured and compared using a within-subject paired analysis. No tissue samples were obtained from the control group.
The primary objective was to determine whether serum periostin levels differ between children with clinically significant adenoid hypertrophy and children with grade 1 adenoid hypertrophy without symptoms attributable to adenoid enlargement. A secondary objective was to evaluate whether periostin expression is increased locally in adenoid tissue compared with paired normal nasopharyngeal mucosa in the same patients.
The study was conducted prospectively after obtaining approval from the institutional ethics committee (Approval No. 8/8.11.04.18), and written informed consent was obtained from the legal guardians of all participants. The study was conducted in accordance with the principles of the Declaration of Helsinki.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
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Fatih
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Istanbul, Fatih, Turecko (Türkiye), 34093
- Bezmialem Vakif University
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
The study population consisted of 37 children aged 2-8 years. The study group included 19 children with grade 3-4 adenoid hypertrophy who were scheduled for adenoidectomy due to clinical indications. The control group included 18 children with grade 1 adenoid hypertrophy and no symptoms attributable to adenoid enlargement. All participants had previously documented negative skin prick test results. Children with a history of allergic rhinitis, asthma, immunodeficiency, chronic systemic or endocrine disease, recent upper respiratory tract infection, or prior adenoid surgery were excluded. Serum samples were obtained from all participants, while adenoid tissue and paired normal nasopharyngeal mucosal samples were obtained only from children undergoing adenoidectomy
Popis
Inclusion Criteria:
Children aged 2-8 years. Children with grade 3-4 adenoid hypertrophy scheduled for adenoidectomy due to clinical indications.
Children with grade 1 adenoid hypertrophy (0-25% nasopharyngeal obstruction) and no symptoms attributable to adenoid enlargement for the control group.
Previously documented negative skin prick test results. Written informed consent obtained from the legal guardians.
Exclusion Criteria:
History of allergic rhinitis. History of asthma. Immunodeficiency. Chronic systemic or endocrine disease. Recent upper respiratory tract infection. Previous adenoid surgery.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: CASE_CONTROL
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Adenoid Hypertrophy (Grade 3-4)
Children aged 2-8 years with grade 3-4 adenoid hypertrophy who were scheduled for adenoidectomy based on their clinical condition. Serum periostin levels were measured in this group. Adenoid tissue and paired normal nasopharyngeal mucosa samples were obtained from the same patients during the clinically indicated surgical procedure for tissue periostin analysis. |
The serum periostin levels were planned to compare between the serum samples that were obtained from the two groups. The evaluation of the periostin levels of adenoid tissue and normal healthy mucosa were also planned. |
|
Control (Grade 1 Adenoid Hypertrophy)
Children aged 2-8 years with grade 1 adenoid hypertrophy (0-25% nasopharyngeal obstruction) who had no symptoms attributable to adenoid enlargement. Serum periostin levels were measured for comparison with the adenoid hypertrophy group. No adenoid tissue samples were obtained from participants in this group. |
The serum periostin levels were planned to compare between the serum samples that were obtained from the two groups. The evaluation of the periostin levels of adenoid tissue and normal healthy mucosa were also planned. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Serum periostin concentration
Časové okno: At baseline, before adenoidectomy
|
Serum periostin levels were measured in children with grade 3-4 adenoid hypertrophy and compared with those in children with grade 1 adenoid hypertrophy without symptoms attributable to adenoid enlargement. |
At baseline, before adenoidectomy
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Periostin concentration in adenoid tissue
Časové okno: During adenoidectomy
|
Periostin concentration in adenoid tissue was measured in children with grade 3-4 adenoid hypertrophy and compared with periostin concentration in paired normal nasopharyngeal mucosa obtained from the same patients. |
During adenoidectomy
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Nazan Degirmenci, Bezmialem Vakif University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 8/8.11.04.2018
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Individual participant-level data will not be shared because of participant privacy and confidentiality considerations. Only aggregate study results will be reported.
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