NCT04653376

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2020

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
Last Updated

December 4, 2020

Status Verified

November 1, 2020

Enrollment Period

7 months

First QC Date

November 5, 2020

Last Update Submit

November 26, 2020

Conditions

TonsillitisTonsillar HypertrophyImmune System Diseases

Keywords

Endoplasmic ReticulumApoptosisİmmune system

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Chronic tonsillitis

Patients with tonsil sizes grade 1 and 2, and tonsillectomy indications included frequently recurrent tonsillary infection, sore throat, and malodorous mouth problems were accepted as the chronic tonsillitis group.

Procedure: Tonsillectomy surgery

Tonsillar hypertrophy

Patients with tonsil size grades 3 and 4 and tonsillectomy indications included obstructive symptoms such as snoring, open mouth breathing, difficulty in breathing, and swallowing problems were accepted as the tonsillar hypertrophy group.

Procedure: Tonsillectomy surgery

Interventions

Tonsillectomy surgeryPROCEDURE

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.

Chronic tonsillitisTonsillar hypertrophy

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Patients who underwent tonsillectomy surgery aged between 2 and 16 years and who were clinically diagnosed with chronic tonsillitis and tonsil hypertrophy by the ENT clinician.

You may qualify if:

  • Patients who underwent tonsillectomy surgery with the clinical diagnosis of chronic tonsillitis and tonsillar hypertrophy.

You may not qualify if:

  • Systemic diseases
  • Other otolaryngological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University

Konya, Selcuklu, 42100, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 30078231BACKGROUND

  • Onal M, Yilmaz T, Bilgic E, Muftuoglu SF, Kuscu O, Gunaydin RO. 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.

    PMID: 25555639BACKGROUND

  • Onal M, Kocak N, Duymus F, Bozkurt MK, Elsurer C, Erdur O, Onal O. Relationship of endoplasmic reticulum stress with the etiopathogenesis of chronic tonsillitis and tonsillar hypertrophy in pediatric patients: a prospective, parallel-group study. Mol Biol Rep. 2021 Jul;48(7):5579-5586. doi: 10.1007/s11033-021-06579-4. Epub 2021 Jul 22.

    PMID: 34292473DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Tonsillar tissues were gathered in groups in accordance with their size and analyzed in regards to Endoplasmic Reticulum stress and apoptosis markers by Real-Time PCR and Western Blotting method.

MeSH Terms

Conditions

TonsillitisImmune System Diseases

Condition Hierarchy (Ancestors)

PharyngitisRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 5, 2020

First Posted

December 4, 2020

Study Start

November 1, 2018

Primary Completion

June 10, 2019

Study Completion

June 10, 2019

Last Updated

December 4, 2020

Record last verified: 2020-11

Locations

TU(1)