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CompletedNCT04653376Updated Dec 4, 2020

Relationship of Endoplasmic Reticulum Stress and Tonsillar Tissue Diseases

An observational study in Tonsillitis, Tonsillar Hypertrophy and Immune System Diseases, sponsored by Selcuk University. Completed at 1 site in Turkey. Open to participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2020-12-04.

Sponsored by Selcuk University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
46
Ages
2 Years to 16 Years
Sex
All
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Study 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.

Read the detailed 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.

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Conditions studied

  • Tonsillitis
  • Tonsillar Hypertrophy
  • Immune System Diseases

Keywords

  • Endoplasmic Reticulum
  • Apoptosis
  • İmmune system
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In context

Tonsillitis

103 studies on the registry are indexed under Tonsillitis; 12 are open to participants now.

This study's enrollment of 46 is below the median of 100 across 15 observational studies indexed under Tonsillitis.

Browse Tonsillitis studies →

Lead sponsor

Selcuk University is the lead sponsor of 258 studies on the registry; 67 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Systemic diseases
  • Other otolaryngological disorders
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
46 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • ProcedureTonsillectomy 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.

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What researchers measure

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.

    Time frame: 2018-2020

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Study locations

1 site
  • Selcuk University
    Konya, Selcuklu 42100, Turkey
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References and documents

Publications

  • 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. Erratum In: Mol Cells. 2019 Jun 30;42(6):501. doi: 10.14348/molcells.2019.1241. PubMed 30078231 ↗
  • 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. PubMed 25555639 ↗
  • 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. PubMed 34292473 ↗

Individual participant data

Plan to share: Undecided — We will share the study protocol after our article has been accepted for publication in a journal.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2018 to primary completion in Jun 2019, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2020
First posted
Dec 4, 2020
StartActual
Nov 1, 2018
Primary completionActual
Jun 10, 2019
CompletionActual
Jun 10, 2019
Last update
Dec 4, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04653376
Lead sponsor
Selcuk University
Responsible party
Merih Onal (Assistant Professor, Selcuk University) — Principal investigator
First posted
Dec 4, 2020
Start date
Nov 1, 2018
Primary completion
Jun 10, 2019
Completion
Jun 10, 2019
Last update
Dec 4, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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