NCT04640610

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

9 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 23, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

June 30, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

Same day

First QC Date

November 19, 2020

Last Update Submit

March 10, 2026

Conditions

Keywords

SARS-CoV-2Angiotensin-converting enzyme 2 (ACE2)Transmembrane serine protease 2 (TMPRSS2)TonsilsAdenoids

Outcome Measures

Primary Outcomes (1)

  • 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.

    9 months

Secondary Outcomes (1)

  • Location of ACE 2 receptor and TMPRSS2 serine protease

    9 months

Study Arms (1)

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.

Other: Storage of operating waste

Interventions

Storage of operating waste of adenoidectomy / tonsillectomy

Adenoidectomy / tonsillectomy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • \- N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Hôpital Mondor

Créteil, 94000, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

Hôpital Lariboisière

Paris, 75010, France

Location

Hôpital Armand Trousseau

Paris, 75012, France

Location

Hôpital Pitié Salpêtrière

Paris, 75013, France

Location

HEGP

Paris, 75015, France

Location

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Hôpital Bichat

Paris, 75018, France

Location

Hôpital Tenon

Paris, 75020, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tonsils and adenoids preserved by cryopreservation and fixed with formalin.

Study Officials

  • Romain Luscan, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR
  • Pierre-Louis Tharaux, MD, PhD

    Institut National de la Santé Et de la Recherche Médicale, France

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2020

First Posted

November 23, 2020

Study Start

June 30, 2021

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations