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

November 17, 2025 updated by: Institut Jean-Godinot

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with Fanconi anaemia
Other: Oral brushing
oral brushing of all oral lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Jean-Godinot

Collaborators

Université de Reims Champagne-Ardenne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

October 1, 2030

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025_RIPH_04_Fanc-Oral

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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