Periostin Levels in Children With Adenoid Hypertrophy

NCT04152746 | Completed

• 1 other identifier: 8/8.11.04.2018
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Periostin is a matricellular protein that has been shown to be a marker of Type 2 inflammation associated with airway eosinophilia. Matricellular proteins are highly expressed at sites of injury or inflammation. Periostin involves tissue fibrosis and remodeling in the nasal mucosa in some of the otolaryngologic diseases. The up-regulation of periostin expression has been shown in allergic rhinitis, chronic rhinosinusitis with nasal polyps , and aspirin intolerant asthma. In the light of these findings the investigators aimed to evaluate the relation between adenoid hypertrophy and periostin levels.

Conditions

Adenoid Hypertrophy

Keywords

Adenoid Hypertrophy; Periostin

Outcome Measures

Primary Outcomes (2)

• Serum Periostin level

  Serum periostin levels of the adenoid group and control group will be compared.

  1 month

• Adenoid tissue Periostin level

  Periostin levels of the adenoid tissue and normal mucosal healthy tissue will be compared.

  1 month

Study Arms (2)

Adenoid group

Periostin levels in the adenoid group

Other: Periostin level

Control Group

Periostin levels in the control group

Other: Periostin level

Interventions

Periostin level OTHER

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.

Adenoid group; Control Group

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Patients that were scheduled to undergo adenoidectomy were included in the study group (adenoid group). The control group comprised of healthy children who had previously been treated for anemia in the out-patient clinic of the Pediatrics Department and were clinically healthy with normal complete blood cell counts at their follow-up visits.

You may qualify if:

• The patients that were scheduled for adenoidectomy
• Healthy subjects that had not any kind of allergy, adenoid hypertrophy symptoms

You may not qualify if:

• The subjects that had any kind of corticosteroid treatment 1 month prior to surgery, and antihistaminic treatment 2 weeks prior to surgery
• To have allergic rhinitis symptoms
• To have high total IgE levels
• To have positive skin prick test
• To have acute respiratory tract infection
• To have asthma To have any kind of endocrin disease

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Adenoid tissue and blood samples were collected.

Study Officials

• Nazan Degirmenci

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: November 5, 2019
• Study Start: October 1, 2019
• Primary Completion: January 10, 2020
• Study Completion: February 2, 2020
• Last Updated: March 11, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)