AdenoidectomyACE2-AVGNCT04640610
Angiotensin-converting Enzyme 2 (ACE2) Expression in Tonsils and Adenoids
An observational study of Adenoidectomy and Tonsillectomy, run by Assistance Publique - Hôpitaux de Paris at 9 sites in France.
Trial summary
The objective of the research is to study the expression of the ACE 2 receptor and the TMPRSS2 serine protease in the tonsils and adenoids of children and adults. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adenoidectomy, Tonsillectomy
- What is being tested?
- Storage of operating waste
- How many people
- 0 participants
- Where
- 9 sitesFrance
- Study dates
- 30 Jun 2021to 30 Jun 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children and adults, without SARS-CoV-2 infection, in whom an adenoidectomy and/or tonsillectomy is performed for their care in the centers of the study.
Who may be able to join
- Children and adults, without SARS-CoV-2 infection, in whom an adenoidectomy and/or tonsillectomy is performed for their care in the hospitals of Assistance Publique-Hôpitaux de Paris participating in the study.
- Holders of parental authority of minor patients and adult patients not opposed to participation in the study.
Who cannot join
- N/A
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Hôpital Mondor
Créteil, 94000
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Hôpital Lariboisière
Paris, 75010
Hôpital Armand Trousseau
Paris, 75012
Hôpital Pitié Salpêtrière
Paris, 75013
HEGP
Paris, 75015
Hôpital Necker-Enfants Malades
Paris, 75015
Hôpital Bichat
Paris, 75018
Hôpital Tenon
Paris, 75020
About this study
Official title: Study of the Expression of Angiotensin-converting Enzyme 2 (ACE2), a Cell Membrane Receptor for SARS-CoV-2 and the TMPRSS2 Serine Protease in Tonsils and Adenoids of Children and Adults
The objective of the research is to study the expression of the ACE 2 receptor and the TMPRSS2 serine protease in the tonsils and adenoids of children and adults.
Read the detailed description
The entry point for SARS-CoV-2 into the body is the nasal and pharyngeal mucosa. Angiotensin-converting enzyme 2 (ACE 2) was quickly identified as the functional receptor for SARS-CoV-2. Furthermore, the TMPRSS2 serine protease is required for the anchoring of the S protein in cell lines. In addition, the most commonly used screening test is a test for viral RNA by RT-PCR on a nasopharyngeal sample because the viral load is high.
The tonsils and adenoids could be a target organ of the virus. In order to study this hypothesis, the expression of ACE 2 and the serine protease TMPRSS2 will be sought in these tissues.
In addition, children, generally at high risk of severe viral respiratory infections (RSV, influenza), have milder symptoms than older patients with SARS-CoV-2 infection. The reason for this difference remains elusive. But one of the hypotheses formulated is that the level of expression of ACE 2 and / or TMPRSS2 may differ between adults and children, the viral load seeming to be correlated with the severity of the attack. In order to study this hypothesis, we will therefore compare the level of expression of ACE 2 in the tonsil tissue of children and adults.
- Conditions
- Adenoidectomy, Tonsillectomy
- Being tested
- Storage of operating waste
- Keywords
- SARS-CoV-2, Angiotensin-converting enzyme 2 (ACE2), Transmembrane serine protease 2 (TMPRSS2), Tonsils, Adenoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Storage of operating wasteOther
Storage of operating waste of adenoidectomy / tonsillectomy
| Study group | Role | What they receive |
|---|---|---|
| Adenoidectomy / tonsillectomy | Children and adults, without SARS-CoV-2 infection, in whom an adenoidectomy and/or tonsillectomy is performed for their care in the centers of the study. Receives: Other: Storage of operating waste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of ACE 2 receptor and TMPRSS2 serine protease
Measurement of expression of ACE 2 receptor and TMPRSS2 serine protease in tonsils and adenoids labeled by immunofluorescence.
Measured: 9 months
Secondary outcomes (1)
Location of ACE 2 receptor and TMPRSS2 serine protease
Location of ACE 2 receptor and TMPRSS2 serine protease in tonsils and adenoids labeled by immunofluorescence.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start30 Jun 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Why it stopped: Abandonment of the study project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenoidectomyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Romain Luscan, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisPierre-Louis Tharaux, MD, PhD, Study director, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640610
- Sponsor's protocol ID
- APHP201032
- Acronym
- ACE2-AVG
- Status last verified
- Mar 2026
- First submitted
- 19 Nov 2020
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Expression of Angiotensin-converting Enzyme 2 (ACE2), a Cell Membrane Receptor for SARS-CoV-2 and the TMPRSS2 Serine Protease in Tonsils and Adenoids of Children and Adults
- ClinicalTrials.gov ID
- NCT04640610
- Acronym / sponsor ID
- ACE2-AVG / APHP201032
- Conditions
- Adenoidectomy, Tonsillectomy
- Keywords
- SARS-CoV-2, Angiotensin-converting enzyme 2 (ACE2), Transmembrane serine protease 2 (TMPRSS2), Tonsils, Adenoids
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Abandonment of the study project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 23 Nov 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.
The objective of the research is to study the expression of the ACE 2 receptor and the TMPRSS2 serine protease in the tonsils and adenoids of children and adults.
Detailed description
The entry point for SARS-CoV-2 into the body is the nasal and pharyngeal mucosa. Angiotensin-converting enzyme 2 (ACE 2) was quickly identified as the functional receptor for SARS-CoV-2. Furthermore, the TMPRSS2 serine protease is required for the anchoring of the S protein in cell lines. In addition, the most commonly used screening test is a test for viral RNA by RT-PCR on a nasopharyngeal sample because the viral load is high.
The tonsils and adenoids could be a target organ of the virus. In order to study this hypothesis, the expression of ACE 2 and the serine protease TMPRSS2 will be sought in these tissues.
In addition, children, generally at high risk of severe viral respiratory infections (RSV, influenza), have milder symptoms than older patients with SARS-CoV-2 infection. The reason for this difference remains elusive. But one of the hypotheses formulated is that the level of expression of ACE 2 and / or TMPRSS2 may differ between adults and children, the viral load seeming to be correlated with the severity of the attack. In order to study this hypothesis, we will therefore compare the level of expression of ACE 2 in the tonsil tissue of children and adults.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adenoidectomy / tonsillectomy | – | Other: Storage of operating wasteChildren and adults, without SARS-CoV-2 infection, in whom an adenoidectomy and/or tonsillectomy is performed for their care in the centers of the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children and adults, without SARS-CoV-2 infection, in whom an adenoidectomy and/or tonsillectomy is performed for their care in the centers of the study.
Key inclusion criteria (2 listed)
- Children and adults, without SARS-CoV-2 infection, in whom an adenoidectomy and/or tonsillectomy is performed for their care in the hospitals of Assistance Publique-Hôpitaux de Paris participating in the study.
- Holders of parental authority of minor patients and adult patients not opposed to participation in the study.
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Storage of operating wasteStorage of operating waste of adenoidectomy / tonsillectomy | Other | Adenoidectomy / tonsillectomy |
Primary outcome
Expression of ACE 2 receptor and TMPRSS2 serine protease
Time frame: 9 months
Measurement of expression of ACE 2 receptor and TMPRSS2 serine protease in tonsils and adenoids labeled by immunofluorescence.
1 secondary outcome
Location of ACE 2 receptor and TMPRSS2 serine protease
Time frame: 9 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Romain Luscan, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Pierre-Louis Tharaux, MD, PhD study director
Institut National de la Santé Et de la Recherche Médicale, France
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenoidectomy and Tonsillectomy, run by Assistance Publique - Hôpitaux de Paris at 9 sites in France.
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 1 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: withdrawn, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. 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 was withdrawn before enrolling participants, so there are no results.
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?
Expression of ACE 2 receptor and TMPRSS2 serine protease (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2026.