Non-invasive Characterisation of Oral Carcinomas in Patie... | NCT07242261

Studies
Non-invasive Characterisation of Oral Carcinomas in Patients With Fanconi Anaemia

NCT07242261

Sponsor

Institut Jean-Godinot

Status

Not yet recruiting

Last Update Posted

Nov 21, 2025Actual

Enrollment

115Estimated

Phase

Not Applicable

Conditions

Fanconi Anaemia

Interventions

Oral brushing

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2026Estimated

Primary Completion Date

Apr 1, 2030Estimated

Completion Date

Oct 1, 2030Estimated

First Submitted Date

Nov 17, 2025

First Submission Date that Met QC Criteria

Nov 17, 2025

First Posted Date

Nov 21, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2025

Last Update Posted Date

Nov 21, 2025Actual

Name	Class
Université de Reims Champagne-Ardenne	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patients with Fanconi anaemia have an increased risk of developing squamous cell carcinoma of the head and neck. In addition, their genetic vulnerability limits the use of genotoxic treatments such as radiotherapy and chemotherapy, due to increased exposure to severe toxicities.

Less invasive diagnostic techniques, such as brush biopsies, which rely on cytological and ploidy analysis, offer the possibility of more systematic, comprehensive and less painful oral mapping, thereby facilitating earlier diagnosis.

Detailed Description

The aim of the study is to investigate the capabilities of oral brushing for the characterisation of oral lesions in patients with Fanconi anaemia.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

115Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with Fanconi anaemia	Experimental		Other: Oral brushing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral brushing	Other	oral brushing of all oral lesions	Patients with Fanconi anaemia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oral brushing	"Positive" result: presence of dysplastic cells at the moderate dysplasia stage or malignant cells. "Negative" result: absence of dysplastic cells beyond the mild dysplasia stage and absence of malignant cells.	Day 0

Secondary Outcomes

Measure	Description	Time Frame
oral lesion biopsy	"Positive" result: presence of dysplastic cells at the moderate dysplasia stage or malignant cells. "Negative" result: absence of dysplastic cells beyond the mild dysplasia stage and absence of malignant cells.	Day 0

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

have Fanconi anaemia
are aged 15 years or older
have at least one oral lesion with or without warning signs
who agree to participate in the study

Exclusion Criteria:

pregnant and breastfeeding women
protected by law (guardianship, curatorship, judicial protection)
refusing to participate in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Barbe / Coralie, DR	Contact	03 26 91 36 65	+33	currs@univ-reims.fr

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003554	Cystinosis

Ancestor Terms

ID	Term
D016464	Lysosomal Storage Diseases
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014099	Toothbrushing

Ancestor Terms

ID	Term
D009910	Oral Hygiene
D011313	Preventive Dentistry
D003813	Dentistry

Browse Leaves

Not provided

Browse Branches

Not provided