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Not yet recruitingNCT07242261Fanc-OralUpdated Nov 21, 2025

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

An interventional study of Oral brushing in Fanconi Anaemia, sponsored by Institut Jean-Godinot. Not yet recruiting. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2025-11-21.

Sponsored by Institut Jean-Godinot · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
115
Allocation
Not applicable
Ages
15 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Fanconi Anaemia

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Keywords

  • Fanconi anaemia
  • oral brushing
  • head and neck carcinoma
03

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • pregnant and breastfeeding women
  • protected by law (guardianship, curatorship, judicial protection)
  • refusing to participate in the study
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
115 participants (estimated)

Study arms

  • Experimental
    Patients with Fanconi anaemia

    Other: Oral brushing

Interventions

  • OtherOral brushing

    oral brushing of all oral lesions

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 0

Secondary outcomes

  1. 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.

    Time frame: Day 0

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07242261
Lead sponsor
Institut Jean-Godinot
Collaborators
Université de Reims Champagne-Ardenne
Responsible party
Sponsor
First posted
Nov 21, 2025
Start date
Apr 1, 2026 (estimated)
Primary completion
Apr 1, 2030 (estimated)
Completion
Oct 1, 2030 (estimated)
Last update
Nov 21, 2025

Study contacts

Barbe / Coralie, DR
Contact
currs@univ-reims.fr
03 26 91 36 65 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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