NCT06094829

Brief Summary

Head and neck cancers represent more than 500,000 cases per year worldwide, and often involve post-treatment relapse. The oral cavity is the most frequent site, but early disease stages are still insufficiently characterised and poorly detected. The study's aim is to better understand the oral mucosa somatic evolution, and how it can give rise to oral squamous cell carcinoma (OSCC). This is a multi-centric, descriptive, non-interventional cohort in healthy adult subjects. The aim of the study is to detect the presence of OSCC driver gene mutations in healthy subjects' oral mucosa, quantify whether they provide cells with a selective advantage, and study the impact of tobacco and alcohol consumption on the mutational load. This study will not allow to identify potential malignant cells, and will be usable for diagnostic purposes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

15 active sites

Status
completed

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

October 16, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

November 23, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2024

Completed
Last Updated

May 5, 2026

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

October 16, 2023

Last Update Submit

May 4, 2026

Conditions

Carcinoma, Squamous Cell

Keywords

Oral cytobrushHealthy oral mucosaOral squamous cell carcinomaTobacco and alcohol

Outcome Measures

Primary Outcomes (1)

  • Prevalence of non-synonymous OSCC driver mutations in the healthy mucosa of smokers

    Difference in mean number of non-synonymous mutations found in OSCC driver genes between smokers and non-smokers.

    12 months

Study Arms (2)

Smokers

Healthy subjects having smoked 100 cigarettes or more during their life.

Other: Oral cytobrush

Non-smokers

Healthy subjects having smoked less than 100 cigarettes during their life.

Other: Oral cytobrush

Interventions

Oral cytobrushOTHER

Oral epithelial cells will be collected during routine odontology appointments, upon documented non-opposition, via minimally invasive cytobrush sampling of the inner cheek

Non-smokersSmokers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects coming to odontology practices for routine visits

You may qualify if:

  • Man or woman aged 18 or more.
  • Subject coming to odontology practice for routine visit.
  • Subject having accepted to participate to the research by oral non-opposition
  • Subject having given additional written consent for genetic studies.
  • Smoking group criterion: subjects having smoked 100+ cigarettes/joints during their life.

You may not qualify if:

  • Personal history of cancer, whichever the type.
  • Treatment with anticoagulants or platelet aggregation inhibitors.
  • Bilateral lesions of the inner cheek preventing painless biological sample collection.
  • Subject under under guardians or curators
  • Pregnancy or breastfeeding
  • Cannabis usage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Cabinet Libéral Picquendar

Bougival, 78380, France

Location

Cabinet Libéral Balayre

Chassieu, 69680, France

Location

Cabinet Libéral Debeauvais

Châtillon-Coligny, 45230, France

Location

Cabinet Libéral Finet

Fontaine-lès-Dijon, 21121, France

Location

Cabinet Libéral Jaeggy

Haguenau, 67500, France

Location

Unité de chirurgie et médecine orales (UCMO) - HCL - Hôpital Edouard Herriot- Pavillon R

Lyon, 69003, France

Location

Centre de Consultations et de Traitements Dentaires HCL

Lyon, 69007, France

Location

Cabinet Libéral Grammatica

Lyon, 69008, France

Location

Cabinet Libéral Cougot

Meudon, 92190, France

Location

Cabinet Libéral Calvo

Quint-Fonsegrives, 31130, France

Location

Cabinet Libéral Glomet

Saumur, 49400, France

Location

Cabinet Libéral Dutour

Theix, 63122, France

Location

Cabinet Libéral Masri

Vandœuvre-lès-Nancy, 54500, France

Location

Cabinet Libéral Bondil

Villefranche-sur-Saône, 69400, France

Location

Cabinet Libéral Janisset-Masse

Villiers-sur-Marne, 95350, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Oral cytobrush samples will be collected (1 per patient, single time point without follow-up) and analysed via deep whole exome sequencing (\>500x).

MeSH Terms

Conditions

Carcinoma, Squamous CellSquamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellHead and Neck NeoplasmsNeoplasms by Site

Study Officials

  • Brigitte GROSGOGEAT, MD

    Centre de Consultations et de Traitements Dentaires HCL, Lyon, 69007

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2023

First Posted

October 23, 2023

Study Start

November 23, 2023

Primary Completion

March 8, 2024

Study Completion

March 8, 2024

Last Updated

May 5, 2026

Record last verified: 2024-06

Locations

FR(15)