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临床试验 NCT05317234 (PREGENE PC) 针对脑瘫目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Genetic Predisposition in Cerebral Palsy (PREGENE PC) 250
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临床试验NCT05317234 (PREGENE PC)是一项针对脑瘫的干预性研究试验，目前试验状态为招募中。试验始于2023年9月8日，计划招募250名患者。该研究由Hospices Civils de Lyon主导，预计于2028年3月8日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年3月3日。
简要概括
Cerebral palsy (CP) is a major neurodevelopmental disorder with an estimated prevalence of approximately one in 500 children. It is characterised by permanent developmental disorders of movement and posture, responsible for activity limitations, caused by non-progressive damage to the brain of the fetus, newborn or infant during development. The neurobiological mechanisms involved in CP remain poorly understood, alth...显示更多
官方标题
Genetic Predisposition in Cerebral Palsy
疾病
脑瘫其他研究标识符
- PREGENE PC
- 69HCL21_0849
NCT编号
实际开始日期
2023-09-08
最近更新发布
2025-03-03
预计完成日期
2028-03-08
计划入组人数
250
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
Cerebral Palsy
Genetic predisposition
Neurodevelopmental disorder
Genetic predisposition
Neurodevelopmental disorder
主要目的
筛查
分配方式
不适用
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性children with cerebral palsy Patients between 2 and 15 years old, born after 34 weeks' gestation, with a diagnosis of cerebral palsy. | 全外显子组测序 The whole-exome sequencing will be performed via a blood sample from a patient with a diagnosis of cerebral palsy. |
主要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Proportion of patients for whom a significant genetic variant was identified on the exome by the High-throughput sequencing technique after comparison with the databases of human polymorphisms and pathogenic variants up to date during the analysis. | Are considered positive for a significant genetic variant, patients for whom a or several class 4 or 5 variants have been identified, and explain the phenotype of pc. Genetic variants will be classified according to the recommendations of the American College of Genetics Medical (ACMG: American College of Medical Genetics) from 1 to 5. | Until the end of study, an average of 4.5 years |
参与助手
资格标准
适龄参与研究
儿童
最低年龄要求
2 Years
适龄性别
全部
- Child between 2 and 15 years old with a clinical diagnostic of cerebral paralysis with unilateral or bilateral somatic involvement
- Child born from 34 SA
- Agreement of the legal representatives for the genetic study
- Both parents available for a parental genetic study (if detection of class 3 variant)
- Affiliation to the social security system
- Genetic syndrome identified or malformative or infectious etiologies identified
- Neonatal encephalopathy criteria in a clear obstetrical etiological context responsible for major perinatal anoxia with Sarnat 2 or 3
- Unilateral motor disorders in perinatal stroke of identified etiology (coagulation anomaly)
Hospices Civils de Lyon研究中心联系人
联系人: Cyril Huissoud, Pr, +33427856565, [email protected]
联系人: Fanny Joubert, +33426732727, [email protected]
2 位于 1 个国家/地区的研究中心
Service de Médecine Physique et Réadaptation Pédiatrique - Hôpital Femme-Mère-Enfant, Bron, 69677, France
Carole VUILLEROT, MD, 联系人, +33 4 72 12 94 50, [email protected]
招募中
Service de médecine physique et réadaptative pédiatrique, Pôle pédiatrie-Génétique - Hôpital Couple-Enfant, Grenoble, France
Véronique BOURG, MD, 联系人, 04 76 76 93 60, [email protected]
尚未招募