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NCT Number: NCT07242261

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

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.

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Key information

Conditions

Fanconi Anaemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystinosis Genetic Diseases, Inborn Lysosomal Storage Diseases Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral brushing

Other

oral brushing of all oral lesions

Primary outcomes

  1. Oral brushing

    Time frame: 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 outcomes

  1. oral lesion biopsy

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Barbe / Coralie, DR

CONTACT

[email protected]

03 26 91 36 65 ext. +33

Sponsors and collaborators

Lead sponsor

Institut Jean-Godinot

Other

Collaborators

  • Université de Reims Champagne-Ardenne

Registry information

Acronym: Fanc-Oral

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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