Enlargement of Tonsil or AdenoidNCT03541434
Bioclinical Profile of Adenotonsillar Hypertrophy in the Pediatric Population
An observational study of Enlargement of Tonsil or Adenoid, run by University of Patras at 2 sites in Greece.
Trial summary
Adenotonsillar hypertrophy is the principal cause of obstructive sleep apnea of childhood, yet little is known with regard to its pathophysiologic and molecular mechanisms. The present trial examines potential bioclinical markers of the disease. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Enlargement of Tonsil or Adenoid
- What is being tested?
- Complete Blood Count, Tympanometry and Tonsillectomy and/or adenoidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 134 participants
- Where
- 2 sitesGreece
- Study dates
- 1 Feb 2017to 30 Jun 2018
- 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 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: All children presenting to the clinics of a Pediatric hospital.
Who may be able to join
- Available history and physical exam findings
- Available complete blood count and tympanometry at admission
Who cannot join
- Previous tonsillectomy and/or adenoidectomy.
- Previous ear surgery.
- Acute infection during the past month.
- Active severe systemic disease.
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Children Hospital of Patras "Karamandaneio"
Pátrai, Achaia, 26331
Patras University Hospital
Rio, Achaia, 26504
About this study
Official title: Analysis of Clinical, Pathologic and Molecular Markers of Adenotonsillar Hypertrophic Disease
Adenotonsillar hypertrophy is the principal cause of obstructive sleep apnea of childhood, yet little is known with regard to its pathophysiologic and molecular mechanisms. The present trial examines potential bioclinical markers of the disease.
Read the detailed description
Background: Tonsils and adenoids comprise the main bulk of Waldeyer's ring, which is commonly enlarged in childhood, until the age of 11. Obstructive sleep apnea caused by adenotonsillar hypertrophy is a major contributing factor to cardiorespiratory morbidity in the pediatric population. It is also responsible for otitis media with effusion, the most frequent cause of children's hearing loss. Even so, there is scarce knowledge of its molecular pathogenesis.
Objective: Identification of clinical/molecular markers of adenotonsillar enlargement and investigation of their participation in the process of tissue hypertrophy.
Methods: A prospective cohort of children with adenotonsillar hypertrophy were recruited starting on 02/01/2017 and ending on 12/22/2017. Demographic and clinical data including age, gender, sleep apnea severity, tonsillar size, presence of middle ear effusion, family history, review of systems as well as tympanometric and complete blood count results were recorded. Blood samples and tissue specimens from the therapeutic adenotonsillectomy procedure were archived for future analyses. Children with chronic tonsillitis and/or adenoiditis, who also underwent excision of tonsils and/or adenoids served as study controls. Informed consent was obtained from parents of all study participants.
- Conditions
- Enlargement of Tonsil or Adenoid
- Being tested
- Complete Blood Count, Tympanometry, Tonsillectomy and/or adenoidectomy
- Keywords
- obstructive sleep apnea, tonsillitis, middle ear effusion, pathophysiology, score
- Medical subject headings
- Sleep Apnea, Obstructive, Tonsillitis, Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete Blood CountDiagnostic test
White blood cell subgroups count
TympanometryDiagnostic test
Conventional and multifrequency tympanometry, documenting middle ear admittance and absorbance
Tonsillectomy and/or adenoidectomyProcedure or surgery
Excision of palatine and/or pharyngeal tonsils.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Children with no history of adenotonsillar hypertrophy, recurrent tonsillitis, or middle ear effusion. They presented to the clinic for examination or a scheduled procedure. Receives: Diagnostic Test: Complete Blood Count; Diagnostic Test: Tympanometry | |
| Recurrent tonsillitis | Children with a history of recurret tonsillitis but no adenotonsillar hypertrophy. Diagnosis was based on physical exam and complete blood count. They presented to the clinic for a sceduled tonsillectomy. Receives: Diagnostic Test: Complete Blood Count; Diagnostic Test: Tympanometry; Procedure: Tonsillectomy and/or adenoidectomy | |
| Middle ear effusion | Children with chronic middle ear effusion but no adenotonsillar hypertrophy. Diagnosis was based on physical exam and tympanometry. They presented to the clinic for scheduled myringotomy with or without adenoidectomy. Receives: Diagnostic Test: Complete Blood Count; Diagnostic Test: Tympanometry; Procedure: Tonsillectomy and/or adenoidectomy | |
| Adenotonsillar hypertrophy | Children with tonsillar and/or adenoidal hypertrophy. Diagnosis was based on physical exam and partly on x-ray of nasopharynx or nasopharyngoscopy. They presented to the clinic for scheduled tonsillectomy and/or adenoidectomy. Receives: Diagnostic Test: Complete Blood Count; Diagnostic Test: Tympanometry; Procedure: Tonsillectomy and/or adenoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioclinical profile of adenotonsillar hypertrophy
Clinical, laboratory, and molecular markers of adenotonsillar hypertrophy
Measured: One year post surgical procedure
Secondary outcomes (5)
Clinical markers of adenotonsillar hypertrophy
Clinical findings from history (sympoms) and physical exam (signs) suggestive of adenotonsillar hypertrophy.
Measured: One year post surgical procedure
Laboratory markers of adenotonsillar hypertrophy
Complete blood count (cells/L)
Measured: One year post surgical procedure
Tympanometric findings of middle ear disease resulting from adenotonsillar hypertrophy
Middle ear pressure (dekaPascals)
Measured: One year post surgical procedure
Wide-Band tympanometric findings of middle ear disease resulting from adenotonsillar hypertrophy
Resonance frequency of the middle ear (Hz)
Measured: One year post surgical procedure
Molecular determinants of adenotonsillar hypertrophy
Immunohistochemical expression of molecular factors involved in tissue growth (semiquantitative scale)
Measured: One year post surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start1 Feb 2017
- Primary completion20 Dec 2017
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Enlargement of Tonsil or AdenoidStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Stathopoulos, University of Patras
- Investigators
- Georgios T Stathopoulos, Principal investigator, Associate Professor of Physiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541434
- Sponsor's protocol ID
- 14/30-09-2016 CHPatras
- Status last verified
- Apr 2019
- First submitted
- 9 May 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Ward SD, Sheldon SH, Shiffman RN, Lehmann C, Spruyt K; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):e714-55. doi: 10.1542/peds.2012-1672. Epub 2012 Aug 27.
PubMed 22926176Liou HC. Regulation of the immune system by NF-kappaB and IkappaB. J Biochem Mol Biol. 2002 Nov 30;35(6):537-46. doi: 10.5483/bmbrep.2002.35.6.537.
PubMed 12470586Heneghan AF, Pierre JF, Kudsk KA. JAK-STAT and intestinal mucosal immunology. JAKSTAT. 2013 Oct 1;2(4):e25530. doi: 10.4161/jkst.25530. Epub 2013 Jun 26.
PubMed 24416649Min HJ, Kim SJ, Kim TH, Chung HJ, Yoon JH, Kim CH. Level of secreted HMGB1 correlates with severity of inflammation in chronic rhinosinusitis. Laryngoscope. 2015 Jul;125(7):E225-30. doi: 10.1002/lary.25172. Epub 2015 Jan 30.
PubMed 25639490Kourelis K, Marazioti A, Kourelis T, Stathopoulos GT. Haematologic Markers and Tonsil-to-Body Weight Ratio to Assist Adenotonsillar Hypertrophy Diagnosis. Indian J Otolaryngol Head Neck Surg. 2022 Dec;74(Suppl 3):5604-5610. doi: 10.1007/s12070-021-02943-9. Epub 2021 Oct 25.
PubMed 36742935
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Clinical, Pathologic and Molecular Markers of Adenotonsillar Hypertrophic Disease
- ClinicalTrials.gov ID
- NCT03541434
- Acronym / sponsor ID
- 14/30-09-2016 CHPatras
- Conditions
- Enlargement of Tonsil or Adenoid
- Keywords
- obstructive sleep apnea, tonsillitis, middle ear effusion, pathophysiology, score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 30 May 2018 (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.
Adenotonsillar hypertrophy is the principal cause of obstructive sleep apnea of childhood, yet little is known with regard to its pathophysiologic and molecular mechanisms. The present trial examines potential bioclinical markers of the disease.
Detailed description
Background: Tonsils and adenoids comprise the main bulk of Waldeyer's ring, which is commonly enlarged in childhood, until the age of 11. Obstructive sleep apnea caused by adenotonsillar hypertrophy is a major contributing factor to cardiorespiratory morbidity in the pediatric population. It is also responsible for otitis media with effusion, the most frequent cause of children's hearing loss. Even so, there is scarce knowledge of its molecular pathogenesis.
Objective: Identification of clinical/molecular markers of adenotonsillar enlargement and investigation of their participation in the process of tissue hypertrophy.
Methods: A prospective cohort of children with adenotonsillar hypertrophy were recruited starting on 02/01/2017 and ending on 12/22/2017. Demographic and clinical data including age, gender, sleep apnea severity, tonsillar size, presence of middle ear effusion, family history, review of systems as well as tympanometric and complete blood count results were recorded. Blood samples and tissue specimens from the therapeutic adenotonsillectomy procedure were archived for future analyses. Children with chronic tonsillitis and/or adenoiditis, who also underwent excision of tonsils and/or adenoids served as study controls. Informed consent was obtained from parents of all study participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Diagnostic Test: Complete Blood Count, Diagnostic Test: TympanometryChildren with no history of adenotonsillar hypertrophy, recurrent tonsillitis, or middle ear effusion. They presented to the clinic for examination or a scheduled procedure. |
| Recurrent tonsillitis | – | Diagnostic Test: Complete Blood Count, Diagnostic Test: Tympanometry, Procedure: Tonsillectomy and/or adenoidectomyChildren with a history of recurret tonsillitis but no adenotonsillar hypertrophy. Diagnosis was based on physical exam and complete blood count. They presented to the clinic for a sceduled tonsillectomy. |
| Middle ear effusion | – | Diagnostic Test: Complete Blood Count, Diagnostic Test: Tympanometry, Procedure: Tonsillectomy and/or adenoidectomyChildren with chronic middle ear effusion but no adenotonsillar hypertrophy. Diagnosis was based on physical exam and tympanometry. They presented to the clinic for scheduled myringotomy with or without adenoidectomy. |
| Adenotonsillar hypertrophy | – | Diagnostic Test: Complete Blood Count, Diagnostic Test: Tympanometry, Procedure: Tonsillectomy and/or adenoidectomyChildren with tonsillar and/or adenoidal hypertrophy. Diagnosis was based on physical exam and partly on x-ray of nasopharynx or nasopharyngoscopy. They presented to the clinic for scheduled tonsillectomy and/or adenoidectomy. |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All children presenting to the clinics of a Pediatric hospital.
Key inclusion criteria (2 listed)
- Available history and physical exam findings
- Available complete blood count and tympanometry at admission
Key exclusion criteria (4 listed)
- Previous tonsillectomy and/or adenoidectomy.
- Previous ear surgery.
- Acute infection during the past month.
- Active severe systemic disease.
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 |
|---|---|---|
| Complete Blood CountWhite blood cell subgroups count | Diagnostic test | Adenotonsillar hypertrophy, Healthy, Middle ear effusion, Recurrent tonsillitis |
| TympanometryConventional and multifrequency tympanometry, documenting middle ear admittance and absorbance | Diagnostic test | Adenotonsillar hypertrophy, Healthy, Middle ear effusion, Recurrent tonsillitis |
| Tonsillectomy and/or adenoidectomyExcision of palatine and/or pharyngeal tonsils. | Procedure or surgery | Adenotonsillar hypertrophy, Middle ear effusion, Recurrent tonsillitis |
Primary outcome
Bioclinical profile of adenotonsillar hypertrophy
Time frame: One year post surgical procedure
Clinical, laboratory, and molecular markers of adenotonsillar hypertrophy
5 secondary outcomes
Clinical markers of adenotonsillar hypertrophy
Time frame: One year post surgical procedure
Laboratory markers of adenotonsillar hypertrophy
Time frame: One year post surgical procedure
Tympanometric findings of middle ear disease resulting from adenotonsillar hypertrophy
Time frame: One year post surgical procedure
Wide-Band tympanometric findings of middle ear disease resulting from adenotonsillar hypertrophy
Time frame: One year post surgical procedure
Molecular determinants of adenotonsillar hypertrophy
Time frame: One year post surgical procedure
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 16 Apr 2019.
- Results publication: PubMed 22926176Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Ward SD, Sheldon SH, Shiffman RN, Lehmann C, Spruyt K; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):e714-55. doi: 10.1542/peds.2012-1672. Epub 2012 Aug 27.
- Results publication: PubMed 12470586Liou HC. Regulation of the immune system by NF-kappaB and IkappaB. J Biochem Mol Biol. 2002 Nov 30;35(6):537-46. doi: 10.5483/bmbrep.2002.35.6.537.
- Results publication: PubMed 24416649Heneghan AF, Pierre JF, Kudsk KA. JAK-STAT and intestinal mucosal immunology. JAKSTAT. 2013 Oct 1;2(4):e25530. doi: 10.4161/jkst.25530. Epub 2013 Jun 26.
- Results publication: PubMed 25639490Min HJ, Kim SJ, Kim TH, Chung HJ, Yoon JH, Kim CH. Level of secreted HMGB1 correlates with severity of inflammation in chronic rhinosinusitis. Laryngoscope. 2015 Jul;125(7):E225-30. doi: 10.1002/lary.25172. Epub 2015 Jan 30.
- Derived from this study: PubMed 36742935Kourelis K, Marazioti A, Kourelis T, Stathopoulos GT. Haematologic Markers and Tonsil-to-Body Weight Ratio to Assist Adenotonsillar Hypertrophy Diagnosis. Indian J Otolaryngol Head Neck Surg. 2022 Dec;74(Suppl 3):5604-5610. doi: 10.1007/s12070-021-02943-9. Epub 2021 Oct 25.
- Individual participant dataSharing planned: Undecided
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Adenotonsillar Hypertrophy
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.
Georgios T Stathopoulos principal investigator
Associate Professor of Physiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enlargement of Tonsil or Adenoid, run by University of Patras at 2 sites in Greece.
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 2 inclusion and 4 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 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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?
Bioclinical profile of adenotonsillar hypertrophy (time frame: One year post surgical procedure). 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 NCT03541434, which also lists 5 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 16 Apr 2019.