TonsillitisNCT04653376
Relationship of Endoplasmic Reticulum Stress and Tonsillar Tissue Diseases
An observational study of Tonsillitis and Tonsillar Hypertrophy, run by Selcuk University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Tonsillitis, Tonsillar Hypertrophy, Immune System Diseases
- What is being tested?
- Tonsillectomy surgery
- Type of treatment
- Surgery or procedure
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 10 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Patients who underwent tonsillectomy surgery with the clinical diagnosis of chronic tonsillitis and tonsillar hypertrophy.
Who cannot join
- Systemic diseases
- Other otolaryngological disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Possible Relationship Between Apoptosis and Endoplasmic Reticulum Stress in the Etiopathogenesis of Chronic Tonsillitis and Tonsillar Hypertrophy
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.
- Conditions
- Tonsillitis, Tonsillar Hypertrophy, Immune System Diseases
- Being tested
- Tonsillectomy surgery
- Keywords
- Endoplasmic Reticulum, Apoptosis, İmmune system
- Medical subject headings
- Tonsillitis, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tonsillectomy surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Tonsillectomy surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2018-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Nov 2018
- Primary completion10 Jun 2019
- Study completion10 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TonsillitisStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merih Onal, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653376
- Sponsor's protocol ID
- 2018/329
- Status last verified
- Nov 2020
- First submitted
- 5 Nov 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will share the study protocol after our article has been accepted for publication in a journal.
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.
PubMed 30078231Onal 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 25555639Onal 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Possible Relationship Between Apoptosis and Endoplasmic Reticulum Stress in the Etiopathogenesis of Chronic Tonsillitis and Tonsillar Hypertrophy
- ClinicalTrials.gov ID
- NCT04653376
- Acronym / sponsor ID
- 2018/329
- Conditions
- Tonsillitis, Tonsillar Hypertrophy, Immune System Diseases
- Keywords
- Endoplasmic Reticulum, Apoptosis, İmmune system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic tonsillitis | – | Procedure: Tonsillectomy surgeryPatients 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. |
| Tonsillar hypertrophy | – | Procedure: Tonsillectomy surgeryPatients 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. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Patients who underwent tonsillectomy surgery with the clinical diagnosis of chronic tonsillitis and tonsillar hypertrophy.
Key exclusion criteria (2 listed)
- Systemic diseases
- Other otolaryngological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tonsillectomy surgeryThe 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. | Procedure or surgery | Chronic tonsillitis, Tonsillar hypertrophy |
Primary outcome
Relationship of Endoplasmic Reticulum stress and apoptosis with chronic tonsillitis and tonsillar hypertrophy
Time frame: 2018-2020
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Background: PubMed 30078231So 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.
- Background: PubMed 25555639Onal 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.
- Derived from this study: PubMed 34292473Onal 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.
- Individual participant dataSharing planned: Undecided. We will share the study protocol after our article has been accepted for publication in a journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tonsillitis and Tonsillar Hypertrophy, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship of Endoplasmic Reticulum stress and apoptosis with chronic tonsillitis and tonsillar hypertrophy (time frame: 2018-2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04653376, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.