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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04653376
Other study ID # 2018/329
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date June 10, 2019

Study information

Verified date November 2020
Source Selcuk University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Tonsillar tissue is a significant organ for the performing of immune systems in children. The Endoplasmic Reticulum (ER), is an organelle needed for the care of a stable function of the cells. The purpose of the study was to explore the correlation among ER stress and tonsillar tissue disorders and to explain the structure of diseases related to the immune system.


Description:

A prospective study was conducted on 46 children aged who underwent tonsillectomy for chronic tonsillitis or tonsil hypertrophy. Tonsil tissues were evaluated in terms of ER stress markers and apoptosis markers by Real-time PCR and Western blot methods.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date June 10, 2019
Est. primary completion date June 10, 2019
Accepts healthy volunteers No
Gender All
Age group 2 Years to 16 Years
Eligibility Inclusion Criteria: - Patients who underwent tonsillectomy surgery with the clinical diagnosis of chronic tonsillitis and tonsillar hypertrophy. Exclusion Criteria: - Systemic diseases - Other otolaryngological disorders

Study Design


Intervention

Procedure:
Tonsillectomy surgery
The tonsillectomy procedure was performed under general anesthesia using the classical dissection method. Extracted tonsil tissue samples were sent to the medical genetics department in tubes to investigate the ER stress and apoptosis.

Locations

Country Name City State
Turkey Selcuk University Konya Selcuklu

Sponsors (1)

Lead Sponsor Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Önal M, Yilmaz T, Bilgiç E, Müftüoglu SF, Kusçu O, Günaydin RÖ. Apoptosis in chronic tonsillitis and tonsillar hypertrophy. Int J Pediatr Otorhinolaryngol. 2015 Feb;79(2):191-5. doi: 10.1016/j.ijporl.2014.12.005. Epub 2014 Dec 15. — View Citation

So JS. Roles of Endoplasmic Reticulum Stress in Immune Responses. Mol Cells. 2018 Aug 31;41(8):705-716. doi: 10.14348/molcells.2018.0241. Epub 2018 Jul 30. Review. Erratum in: Mol Cells. 2019 Jun 30;42(6):501. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Relationship of Endoplasmic Reticulum stress and apoptosis with chronic tonsillitis and tonsillar hypertrophy Our primary outcome was to evaluate providing that Endoplasmic Reticulum stress and apoptosis reaction performing in chronic tonsillitis and tonsillar hypertropy, which is related with the immune system of children. GRP78, CHOP, ATF6, ATF4 proteins will be investigated in tonsillar tissues to evaluate ER stress index, and bax, bcl2 proteins will be investigated to evaluate apoptosis. 2018-2020
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