Endoscopic Follow-up of Low Grade Precancerous Bronchial Lesions in High Risk Patients (SELEPREBB1)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 365
- 试验地点
- 1
- 主要终点
- occurence of high grade lesion or occurence of a cancer during endoscopic or clinical follow up
研究概览
简要总结
The goal of this multicentric French randomized trial is to determine the best auto fluorescence bronchial endoscopic follow-up strategy in high risk patients bearing low grade bronchial precancerous lesions. Subjects will be randomly assigned to one of the following arm :
(A) every 6 months clinical and chest Xrays follow-up without intermediate endoscopy, (B) every 6 months clinical and chest Xrays follow-up including repeated autofluorescence endoscopy and biopsies on a 6 months basis in case of low grade dysplasia or on a one year basis in patients without dysplasia.
After 36 months follow-up, each patient from the two groups will be subjected to a final autofluorescence endoscopy and biopsy and a Spiral Chest Xray.
The final analysis will compare between the two groups :
- The probability of progression from an initially identified low grade lesion to a high grade lesion
- The probability of respiratory epithelial tract progression assessed by the occurrence of a lung cancer or high grade lesion.
- The characteristics of lung cancers detected in each arm
- In both arm, the influence of risk factors and persistent exposure to tobacco on lesion evolutivity.
详细描述
The goal of this multicentric French randomized trial is to determine the best auto fluorescence bronchial endoscopic follow-up strategy in high risk patients bearing low grade bronchial precancerous lesions. This Trial compares two follow-up modalities : observation without endoscopy for a three year period (group A " light " follow-up), versus repeated autofluorescence endoscopies and biopsies every six months for three years (group B " intensive ").
Methods: 300 subjects at high risk for lung cancer will be included over a two year period and followed-up for three years. In each subject an auto-fluorescence endoscopy and a Chest CT scan will be performed before the enrollment into the trial. To be included the subject must present with an initial Chest CT scan not suspicious for lung cancer and bronchial biopsy showing a moderate dysplasia or a lower grade lesion.
Subjects will be randomly assigned to one of the following arm :
(A) every 6 months clinical and chest Xrays follow-up without intermediate endoscopy, (B) every 6 months clinical and chest Xrays follow-up including repeated autofluorescence endoscopy and biopsies on a 6 months basis in case of low grade dysplasia or on a one year basis in patients without dysplasia.
Stratifications factors for randomization are: Center, occupational exposure to respiratory carcinogens, presence of a bronchial low dysplastic lesion versus absence of dysplasia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with one or several of the following risk factor for lung cancer:
- •Tobacco consumption more than 30 pack years
- •Lung or ENT cancer history, cured
- •Occupational exposure to respiratory carcinogens
- •Normal baseline CT scan
- •Autofluorescence endoscopy showing moderate dysplasia or lower grade lesion
- •Written informed consent
排除标准
- •Treatment with Vit A derivative
- •Contra indication for a fiberoptic bronchoscopy under local anesthesia.
- •Known evolutive cancer
- •Chest radiation therapy within 5 years before inclusion or chemotherapy within two years before inclusion.
- •Impossibility for a 3 years follow-up
结局指标
主要结局
occurence of high grade lesion or occurence of a cancer during endoscopic or clinical follow up
时间窗: 3 years
次要结局
未报告次要终点