Fanconi AnaemiaFanc-OralNCT07242261
Non-invasive Characterisation of Oral Carcinomas in Patients With Fanconi Anaemia
A study testing Oral brushing in people with Fanconi Anaemia, run by Institut Jean-Godinot.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Fanconi Anaemia
- What is being tested?
- Oral brushing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnant and breastfeeding women
- protected by law (guardianship, curatorship, judicial protection)
- refusing to participate in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Fanconi Anaemia
- Being tested
- Oral brushing
- Keywords
- Fanconi anaemia, oral brushing, head and neck carcinoma
- Medical subject headings
- Cystinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral brushingOther
oral brushing of all oral lesions
| Study group | Role | What they receive |
|---|---|---|
| Patients with Fanconi anaemia | Experimental | Not described Receives: Other: Oral brushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fanconi AnaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Jean-Godinot
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Reims Champagne-Ardenne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242261
- Sponsor's protocol ID
- 2025_RIPH_04_Fanc-Oral
- Acronym
- Fanc-Oral
- Status last verified
- Oct 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Characterisation of Oral Carcinomas in Patients With Fanconi Anaemia
- ClinicalTrials.gov ID
- NCT07242261
- Acronym / sponsor ID
- Fanc-Oral / 2025_RIPH_04_Fanc-Oral
- Conditions
- Fanconi Anaemia
- Keywords
- Fanconi anaemia, oral brushing, head and neck carcinoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Institut Jean-GodinotUniversity, hospital or other
- Collaborators
- Université de Reims Champagne-Ardenne
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Fanconi anaemia | Experimental | Other: Oral brushing |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- pregnant and breastfeeding women
- protected by law (guardianship, curatorship, judicial protection)
- refusing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral brushingoral brushing of all oral lesions | Other | Patients with Fanconi anaemia |
Primary outcome
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.
1 secondary outcome
oral lesion biopsy
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Oral brushing in people with Fanconi Anaemia, run by Institut Jean-Godinot.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbe / Coralie, DR (03 26 91 36 65 ext. +33, currs@univ-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral brushing (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.