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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07242261

Acronym

Fanc-Oral

Enrollment

115

Registered

2025-11-21

Start date

2026-04-01

Completion date

2030-10-01

Last updated

2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fanconi Anaemia

Keywords

Fanconi anaemia, oral brushing, head and neck carcinoma

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.

Interventions

OTHEROral brushing

oral brushing of all oral lesions

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Oral brushing	Day 0	* 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.

Secondary

Measure	Time frame	Description
oral lesion biopsy	Day 0	* 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.

Contacts

Primary ContactBarbe / Coralie, DR

currs@univ-reims.fr03 26 91 36 65

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026