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临床试验/NCT07201701
NCT07201701尚未招募不适用

Is CYP24A1 Heterozygosity a Risk Factor for Nephrolithiasis?

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年12月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
45
试验地点
2
主要终点
Prevalence of nephrolithiasis in patients who are CYP24A1 heterozygous and homozygous (or compound heterozygous)

研究概览

简要总结

Biallelic loss-of-function variants in CYP24A1 have been identified as a common genetic cause of autosomal recessive hypercalcemia (ARH, ORPHA 300547, 1 in 80,000 live births), characterized by low PTH (parathyroid hormone) levels, a high 25-OH D/24,25-(OH)₂D ratio, and susceptibility to vitamin D intoxication.

In humans, heterozygous pathogenic variants in CYP24A1 have been proposed both as responsible for an autosomal dominant disorder and as a risk factor for nephrolithiasis, but the rarity and heterogeneity of human data prevent a definitive answer to this crucial question.

Nephrolithiasis is a complex disease in which nutritional factors - particularly sodium and protein intake (leading to hypercalciuria) - play a key role. It also has a heritability of 50%, suggesting the involvement of many genetic susceptibility factors, as well as monogenic forms (mainly autosomal recessive, but also dominant or X-linked), which have been identified in 10-20% of patients.

The increasing prevalence of nephrolithiasis, affecting approximately 10% of the general population over a lifetime, has a significant financial impact on healthcare systems and imposes a major burden of morbidity, justifying further investigation into the genetic underpinnings of nephrolithiasis.

The goal of the HeteroCYP project is to improve understanding of the phenotypes associated with heterozygous, compound heterozygous, and homozygous variants of CYP24A1 by comparing clinical and biological outcomes in patients according to their mutation type

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
2 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Group 1: Heterozygous Patients
  • Aged between 2 and 90 years
  • Weight > 12 kg
  • Carriers of a heterozygous CYP24A1 mutation
  • With or without symptoms: history of nephrocalcinosis or kidney stones
  • Group 2: Homozygous / Compound Heterozygous Patients
  • Aged between 2 and 90 years
  • Weight > 12 kg
  • Carriers of a homozygous or compound heterozygous CYP24A1 mutation
  • With or without symptoms: history of nephrocalcinosis or kidney stones

排除标准

  • Individuals unable to collect 24-hour urine
  • Individuals unable to be available for a full day in a day hospital (HDJ)
  • Pregnant, postpartum, or breastfeeding women
  • Individuals deprived of liberty by judicial or administrative decision
  • Individuals receiving psychiatric care
  • Individuals admitted to a healthcare or social institution for reasons other than participation in research
  • Adults under legal protection (guardianship or trusteeship)
  • Individuals not affiliated with a social security system or not benefiting from an equivalent scheme

研究组 & 干预措施

Patients carriers of a heterozygous CYP2A1 mutation

Patients carriers of a heterozygous CYP2A1 mutation with or without symptoms: history of nephrocalcinosis or nephrolithiasis

干预措施: Supplementary blood samples for PBMC analysis at V2 (Biological)

Patients carriers of homozygous, and compound heterozygous CYP2A1 mutation

Patients carriers of homozygous, and compound heterozygous CYP2A1 mutation with or without symptoms: history of nephrocalcinosis or nephrolithiasis

干预措施: Supplementary blood samples for PBMC analysis at V2 (Biological)

结局指标

主要结局

Prevalence of nephrolithiasis in patients who are CYP24A1 heterozygous and homozygous (or compound heterozygous)

时间窗: Visit 2 (at least 24 hours after baseline)

Prevalence of nephrolithiasis (based on imaging) in patients who are CYP24A1

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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