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临床试验/NCT06694506
NCT06694506招募中不适用

BELux Children OutcoME During A(@)Dulthood With Growth Hormone Deficiency

Cliniques universitaires Saint-Luc- Université Catholique de Louvain1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年5月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Determine the proportion of adult CO-GHD patients who continue to receive regular. medical follow-up

研究概览

简要总结

Our objective is to evaluate the outcome in adulthood of Belgian and Luxembourgish patients treated with rhGH during childhood for CO-GHD. The primary goal is to determine the proportion of adult CO-GHD patients who continue to receive regular medical follow-up and those still undergoing rhGH therapy using a questionnaire. Secondary objectives include assessing the regularity of follow-up and compliance with treatment in adulthood, evaluating possible comorbidities, health issues, lifestyle, living environment, and quality of life. Additionally, we aim to assess the metabolic profile in adulthood, particularly focusing on BMI, glycemic, and lipid data, for patients who consent to share their current clinical and biological data. Data will be described according to treatment adherence and CO-GHD etiology/phenotypes (e.g., idiopathic vs. organic GHD, isolated vs. combined GHD, partial vs. severe GHD).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age > or = 18 years
  • •Diagnosed with child-hood onset growth hormone deficiency (CO-GHD) (no

排除标准

  • •isolated or multiple GHD, idiopathic or organic, severe or partial)
  • •Registered in the BELGROW registry (informed consent at the time of inclusion in registry)
  • •Stopped treatment with rhGH for growth after 2011
  • •Persistent GHD at the end of growth
  • •Exclusion Criteria:
  • •No exclusion criteria

研究组 & 干预措施

Patients with regular follow-up for their GHD (treated with rhGH or not)

No Intervention

Patients with regular follow-up for their GHD (treated with rhGH or not) in a adult endocrinology department including a clinical examination and endocrine blood work-up at least once a year

Patients who are lost to follow-up or not regularly followed for their GHD

Active Comparator

Patients who are lost to follow-up or not regularly followed for their GHD (or only followed by their GP with no endocrine assessment)

干预措施: Biological Sample (Other)

结局指标

主要结局

Determine the proportion of adult CO-GHD patients who continue to receive regular. medical follow-up

时间窗: Baseline

Using our questionnaire, the primary objective is to determine the proportion of adult CO-GHD patients who continue to receive regular medical follow-up (and where/by who) and the proportion of patients still undergoing rhGH therapy.

次要结局

  • Assessment of the regularity of follow-up and compliance with a questionnaire.(Baseline)
  • Assessment of the possible comorbidities and health issues with a questionnaire.(Baseline)
  • Assessment of the metabolic profile in adulthood.(1 year per patient)
  • Describe those data according to treatment adherence.(Baseline)

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Sponsor

研究点 (1)

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