Non-invasive Characterisation of Oral Carcinomas in Patients With Fanconi Anaemia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 115
- 主要终点
- Oral brushing
研究概览
简要总结
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.
详细描述
The aim of the study is to investigate the capabilities of oral brushing for the characterisation of oral lesions in patients with Fanconi anaemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •pregnant and breastfeeding women
- •protected by law (guardianship, curatorship, judicial protection)
- •refusing to participate in the study
结局指标
主要结局
Oral brushing
时间窗: 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.
次要结局
- oral lesion biopsy(Day 0)