Adenoiditis Acute InfectiveNCT04583631
Relationship of Endoplasmic Reticulum Stress and Adenoid Diseases
An observational study of Adenoiditis Acute Infective, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Adenoid 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 cells. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Adenoiditis Acute Infective
- What is being tested?
- Adenoidectomy surgery
- Type of treatment
- Surgery or procedure
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 1 Aug 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 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Study population: This study was performed on 54 patients (28 male, 26 female) between the ages of 3 and 9 (mean 5) with the clinical diagnosis of chronic adenoiditis and adenoid hypertrophy and who underwent adenoidectomy due to either chronic adenoiditis or adenoid hypertrophy.
Who may be able to join
- Patients with the clinical diagnosis of chronic adenoiditis and adenoid hypertrophy.
Who cannot join
- Systemic diseases
- Other otolaryngological
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Apoptosis and er Stress in Chronic Adenoiditis and Adenoid Hypertrophy
Adenoid 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 cells. The purpose of the study was to explore the correlation among ER stress and adenoid tissue disorders and to explain the structure of diseases related to the immune system.
- Conditions
- Adenoiditis Acute Infective
- Being tested
- Adenoidectomy surgery
- Keywords
- Adenoidectomy, ; Endoplasmic Reticulum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adenoidectomy surgeryProcedure or surgery
All patients underwent adenoidectomy under general anesthesia by routine curettage method and adenoid tissues were put in formaldehyde and sent to the genetics department for the exploration of ER stress and apoptosis markers.
| Study group | Role | What they receive |
|---|---|---|
| Chronic adenoiditis | Patients with hypertrophy and those out of hypertrophy were determined and those who had purulant rhinorrhea signs and rate of adenoids-choana below 50% were categorized that chronic adenoiditis. Receives: Procedure: Adenoidectomy surgery | |
| Adenoid hypertrophy | Patients who have snoring and those whose adenoid choana rate is greater than 50% were categorized that adenoid hypertrophy group. Receives: Procedure: Adenoidectomy surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of ER stress and apoptosis with chronic adenoiditis and adenoid hypertrophy
Our primary outcome was to evaluate providing that ER stress and apoptosis reaction performing in chronic adenoiditis and adenoid hypertropy, which is related with the immune system of children.
Measured: 2018-2019 (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start1 Nov 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adenoiditis Acute InfectiveStudies 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
- 54 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
- NCT04583631
- Sponsor's protocol ID
- 2018-18
- Status last verified
- Sep 2021
- First submitted
- 5 Oct 2020
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will share study protocol after our article has been accepted for publication in a journal.
Publications
Casselbrant ML. What is wrong in chronic adenoiditis/tonsillitis anatomical considerations. Int J Pediatr Otorhinolaryngol. 1999 Oct 5;49 Suppl 1:S133-5. doi: 10.1016/s0165-5876(99)00147-0.
PubMed 10577791Li R, Wang Y, Chen P, Meng J, Zhang H. Inhibiting endoplasmic reticulum stress by activation of G-protein-coupled estrogen receptor to protect retinal astrocytes under hyperoxia. J Biochem Mol Toxicol. 2021 Feb;35(2):e22641. doi: 10.1002/jbt.22641. Epub 2020 Sep 29.
PubMed 32996202
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Apoptosis and er Stress in Chronic Adenoiditis and Adenoid Hypertrophy
- ClinicalTrials.gov ID
- NCT04583631
- Acronym / sponsor ID
- 2018-18
- Conditions
- Adenoiditis Acute Infective
- Keywords
- Adenoidectomy, ; Endoplasmic Reticulum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 12 Oct 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.
Adenoid 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 cells. The purpose of the study was to explore the correlation among ER stress and adenoid tissue disorders and to explain the structure of diseases related to the immune system.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic adenoiditis | – | Procedure: Adenoidectomy surgeryPatients with hypertrophy and those out of hypertrophy were determined and those who had purulant rhinorrhea signs and rate of adenoids-choana below 50% were categorized that chronic adenoiditis. |
| Adenoid hypertrophy | – | Procedure: Adenoidectomy surgeryPatients who have snoring and those whose adenoid choana rate is greater than 50% were categorized that adenoid hypertrophy group. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study was performed on 54 patients (28 male, 26 female) between the ages of 3 and 9 (mean 5) with the clinical diagnosis of chronic adenoiditis and adenoid hypertrophy and who underwent adenoidectomy due to either chronic adenoiditis or adenoid hypertrophy.
Key inclusion criteria (1 listed)
- Patients with the clinical diagnosis of chronic adenoiditis and adenoid hypertrophy.
Key exclusion criteria (2 listed)
- Systemic diseases
- Other otolaryngological
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 |
|---|---|---|
| Adenoidectomy surgeryAll patients underwent adenoidectomy under general anesthesia by routine curettage method and adenoid tissues were put in formaldehyde and sent to the genetics department for the exploration of ER stress and apoptosis markers. | Procedure or surgery | Adenoid hypertrophy, Chronic adenoiditis |
Primary outcome
Correlation of ER stress and apoptosis with chronic adenoiditis and adenoid hypertrophy
Time frame: 2018-2019 (1 year)
Our primary outcome was to evaluate providing that ER stress and apoptosis reaction performing in chronic adenoiditis and adenoid hypertropy, which is related with the immune system of children.
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 27 Sep 2021.
- Background: PubMed 10577791Casselbrant ML. What is wrong in chronic adenoiditis/tonsillitis anatomical considerations. Int J Pediatr Otorhinolaryngol. 1999 Oct 5;49 Suppl 1:S133-5. doi: 10.1016/s0165-5876(99)00147-0.
- Background: PubMed 32996202Li R, Wang Y, Chen P, Meng J, Zhang H. Inhibiting endoplasmic reticulum stress by activation of G-protein-coupled estrogen receptor to protect retinal astrocytes under hyperoxia. J Biochem Mol Toxicol. 2021 Feb;35(2):e22641. doi: 10.1002/jbt.22641. Epub 2020 Sep 29.
- Individual participant dataSharing planned: Undecided. We will share study protocol after our article has been accepted for publication in a journal.
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 Adenoiditis Acute Infective, 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 27 Sep 2021. 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?
Correlation of ER stress and apoptosis with chronic adenoiditis and adenoid hypertrophy (time frame: 2018-2019 (1 year)). 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 NCT04583631, which also lists 2 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 27 Sep 2021.