Collection of Primary Human

NCT06407102 | Not Yet Recruiting DMC

• 1 other identifier: DR230317
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Treatment and prevention of respiratory infections are of great interest in many medical areas. Create a physical device covered by primary human nasal cells could be very usefull in order to analyse delivery and efficiency of drugs. In this context the aim of this project is to create a collection of primary cells from the human nasal epithelium. This collection will be realised during programmed surgery, thanks to a specific device dedicated to collect nasal cells. Then the cells will be sent to the lab in order to grow at the air-liquid interface, which is an excellent 'ex vivo' model for their study.

Conditions

Nasal Disease

Keywords

nasal cells; Respiratory epithelium

Outcome Measures

Primary Outcomes (1)

• Percentage of viability of nasal epithelial cells from the operating room to laboratory

  Collect nasal epithelial cells that can be grown in vitro in an air-liquid interface

  6 hours

Secondary Outcomes (1)

• Percentage of efficacy of the procedure

  3 years

Study Arms (1)

Patient with programmed surgery

OTHER

Patient programmed with surgery of meatotomy, septoplasty or turbinoplasty, or other programmed surgeries

Other: Collection of nasal cells during programme surgery

Interventions

Collection of nasal cells during programme surgery OTHER

During programmed surgery (meatotomy, septoplasty or turbinoplasty for example, or other programmed surgeries), the surgeon will take an atraumatic sample from the nasal cavity using a dedicated device (brush) from the healthy nasal mucosa.

Patient with programmed surgery

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (age \> 18 years) whose native language is French, or who understands French.
• Affiliation with a French social security system (CMU accepted).
• Informed consent, written and signed by the participant.
• Planned rhinological surgery (meatotomy, septoplasty or turbinoplasty for example, but other surgeries as well)

You may not qualify if:

• Patients under court protection, guardianship or curatorship.
• Pregnant or breast-feeding women (positive pregnancy test for women of childbearing age).
• Patients presenting a major alteration of the mucosa or a malignant rhinosinus pathology.

Sponsors & Collaborators

• University Hospital, Tours: lead

MeSH Terms

Conditions

Nose Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Charles Aussedat, MD

CONTACT

0247474747; c.aussedat@chu-tours.fr

Adeline Mousset

CONTACT

0218370645; a.fourmy@chu-tours.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: June 30, 2024
• Primary Completion (Estimated): May 2, 2027
• Study Completion (Estimated): May 2, 2028
• Last Updated: June 3, 2024

Record last verified: 2024-05