NCT07242261

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
54mo left

Started Apr 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Apr 2026Oct 2030

First Submitted

Initial submission to the registry

November 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2030

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2030

Last Updated

November 21, 2025

Status Verified

October 1, 2025

Enrollment Period

4 years

First QC Date

November 17, 2025

Last Update Submit

November 17, 2025

Conditions

Fanconi Anaemia

Keywords

Fanconi anaemiaoral brushinghead and neck carcinoma

Outcome Measures

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.

    Day 0

Secondary Outcomes (1)

  • oral lesion biopsy

    Day 0

Study Arms (1)

Patients with Fanconi anaemia

EXPERIMENTAL
Other: Oral brushing

Interventions

Oral brushingOTHER

oral brushing of all oral lesions

Patients with Fanconi anaemia

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cystinosis

Interventions

Toothbrushing

Condition Hierarchy (Ancestors)

Lysosomal Storage DiseasesMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Oral HygienePreventive DentistryDentistry

Central Study Contacts

Barbe / Coralie, DR

CONTACT

03 26 91 36 65currs@univ-reims.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 21, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

October 1, 2030

Last Updated

November 21, 2025

Record last verified: 2025-10