Clinical trial · Interventional
Cytological Screening for Early Diagnosis of Precancerous or Cancerous Lesions of Oral Cavity
Interest of Cytological Screening for Early Diagnosis of Precancerous or Cancerous Lesions of Oral Cavity by Transepithelial Brushing in Liquid-based
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective study of diagnosis validation of a cytological technique. 200 patients with oral cavity cancerous and precancerous lesions will be enrolled. A cytological sample of the lesion will be performed by transepithelial brushing ( Orcellex® Rovers brush) in cytology liquid-based technology (methode ThinPrep 2000 (Hologic®)). A microscopic double blind reading will be performed. A biopsy sampling will be carried out in accordance with current strategy of screening. The brushing diagnosis quality will be compared to the biopsy which is the gold standard.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mouth Neoplasms | Oral Cavity Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Orcellex® Rovers brush | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- transepithelial brushing
- description
- transepithelial brushing in liquid-based technology + biopsy
- interventionNames
- Device: Orcellex® Rovers brush
Primary outcomes (1)
- measure
- Diagnostic validity of lesion (Bethesda system, 2001)
- timeFrame
- baseline
- description
- Diagnostic validity (specificity and sensibility, the classification of lesions is performed according Bethesda system, 2001 and the reference is the histology of biopsy of lesion
Secondary outcomes (4)
- measure
- Diagnostic validity - predictive value (positive and negative)
- timeFrame
- baseline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * one or several cancerous or pre-cancerous lesions of oral cavity newly diagnosed or detected during a follow-up visit Exclusion Criteria: * pregnant or lactating women * patients under juridical protection
References
Publications (0)
Data not yet available