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

I

Institut Jean-Godinot

Status

Begins enrollment in 1 month

Conditions

Fanconi Anaemia

Treatments

Other: Oral brushing

Study type

Interventional

Funder types

Other

Identifiers

NCT07242261
2025_RIPH_04_Fanc-Oral

Details and patient eligibility

About

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.

Full 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.

Enrollment

115 estimated patients

Sex

All

Ages

15+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

115 participants in 1 patient group

Patients with Fanconi anaemia
Experimental group
Treatment:
Other: Oral brushing

Trial contacts and locations

0

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Central trial contact

Barbe / Coralie, DR

Data sourced from clinicaltrials.gov

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