NCT04137133招募中不适用
Patienthèque of Finisterian (South of Brittany) Children With Cystic Fibrosis in the Time of Precision Medicine.Descriptive Monocentric Study for Identification and Validation of Biomarkers Predictive of Clinical Evolution
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Presence of P. aeruginosa in bacterial sputum cultures in one of bronchial secretions sample
研究概览
简要总结
The objective of this study is to evaluate the relevance of Porphyromonas as a biomarker predicting the risk of P. aeruginosa primocolonization in children form 0 to 18 years old with cystic fibrosis.
详细描述
This is a monocentric study in 3 phases:
- Pre-inclusion: at the first visit to the CRCM (support for a positive screening confirmed by sweat test and genotyping CFTR)
- Inclusion: possible between the 2nd visit to the CRCM (about 2 months old) and the 6th month
- Follow-up: up to 36 months old. The pace of visits will be based on the usual follow-up rate of CF infants Clinical and paraclinical data and samples will be collected as part of the usual follow-up of CF children. Inclusions and follow-up visits will be carried out at the Roscoff CRCM as well as respiratory explorations and biological samples. Dermatological and odontological follow-ups will be scheduled for each patient at the rate of an annual visit to the CHRU in Brest in the relevant departments.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly screened infants with a confirmed diagnosis of cystic fibrosis in its classic form (clinical symptoms and two positive sweat tests and/or two mutations of the cftr gene from Class I to III)
- •Children free of any colonization with P. aeruginosa
- •Affiliation with the social security system
- •Consent signed by the holders of parental authority or the sole parent holding parental authority
排除标准
- •Children colonized with P. aeruginosa according to the cytobacteriological examination and / or molecular test of sputum or pharyngeal specimens
- •Children grafted
- •Children not affiliated to a social security scheme or not entitled to
- •Children whose parent (s) are (are) minor (s)
- •Children whose holders of parental authority do not master the French language
- •Refusal to participate in the study
结局指标
主要结局
Presence of P. aeruginosa in bacterial sputum cultures in one of bronchial secretions sample
时间窗: 3 years
Analyse with Porphyromonas predictive biomarker of the risk of P. aeruginosa primocolonization.
次要结局
未报告次要终点
研究者
研究点 (2)
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