Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 33
- 主要终点
- prevalence of gastroesophageal reflux disease (GERD) in children born with esophageal atresia
研究概览
简要总结
Oesophageal atresia (OAEA), a malformation of the oesophagus present from birth, is characterized by the interruption of the continuity of the oesophagus, which then ends in a cul-de-sac. (Source: Fimatho) An operation is then required to restore continuity to the esophagus. Although this operation enables the vast majority of children to survive the neonatal period, health problems such as gastro-oesophageal reflux, eating difficulties, respiratory problems and growth problems persist throughout life.
The aim of the project is to create a prospective cohort of adolescents aged 13/14, nested in the national AO registry. of adolescents born with esophageal atresia, including a biobank of esophageal mucosa and plasma blood samples. Once the clinical and omic data have been collected, the data will be transferred to the France Cohortes information system for analysis, in order to assess the long-term outcome of this rare disease and establish multi-omic profiles. Once the clinical data have been collected and the omics data (derived from analysis of the biobank's biological samples) have been generated, they will be analyzed by the project partners to assess the long-term outcome of OA and establish multiomic profiles. The raw data will be available on the France Cohorte platform.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For the oesophageal atresia group :
- •Born with oesophageal atresia (EA) in France or in French overseas departments and territories
- •Anastomosis performed
- •Included into the ReNaTo registry
- •Aged 13 or 14 during the recruitment period
- •Patient willing to comply with all study procedures and duration
- •Patient will social security
- •For the blood sub-study :
- •Upper GI endoscopy performed as part of care between 13 and 14 years of age with esophageal mucosal biopsy sampling
- •Patient having given written consent to participate in the study
- •For the control arm:
- •Upper GI endoscopy performed as part of care between 10 and 14 years of age with oesophageal mucosal biopsy sampling
- •Upper GI endoscopy performed as part of care for chronic or acute digestive signs to rule out organic etiology (peptic esophagitis, gastric esophagitis, eosinophilic esophagitis or ulcer)
- •Normal endoscopy and histology
- •No chronic progressive disease
排除标准
- •For the oesophagal atresia arm :
- •Concurrent participation in an interventional trial and in the 3 months prior to inclusion
- •Parents refusing to participate in the study
- •For the control arm :
- •Histologically non-normal esophageal biopsy
- •Parents refusing to participate in the study
- •Child with known organic pathology
研究组 & 干预措施
control arm
Patient without esophageal atresia
干预措施: Questionnaire (Other)
Esophageal atresia arm
Patient with esophageal atresia
干预措施: Questionnaire (Other)
结局指标
主要结局
prevalence of gastroesophageal reflux disease (GERD) in children born with esophageal atresia
时间窗: 13-14 years
GERD = \[pH/impedance-metry demonstrating pathological GERD and/or if lesions of peptic esophagitis are observed at an endoscopy in the year preceding the visit or if the child has a history of complicated GERD leading to anti-reflux surgery\]
次要结局
- Quality of life, nutritional status and respiratory complications(13-14 years)
- Omics and multi omics profiles in plasma(13-14 years)
- Factors associated with GERD(Birth,1 year, 6 years and 13-14 years)
- Omics and multi omics profiles in esophageal biopsiesfor patient having 1 biopsy(13-14 years)
- Omics and multi omics profiles in esophageal biopsies for patient having more than 1 biopsy(13-14 years)