HORMONAL ROLE IN VERNAL KERATOCONJUNCTIVITIS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- To assess the difference in serum total testosterone levels between the population of subjects with active VKC and the population of subjects with resolved VKC.
研究概览
简要总结
VKC is more common in males and tends to resolve with pubertal development. Clinical observation was not followed by an investigation that clarified whether there is a correlation between the hormonal pattern and the evolution of the disease, in particular it is not defined whether there is a correlation between the hormonal pattern and the resolution of the disease.
This study aims to evaluate the hormonal pattern in patients with VKC and, in particular, the possible role of these hormones in the resolution of this condition in puberty.
详细描述
The study presents a retrospective and prospective transversal observational design, non-pharmacological, monocentric, non-profit.
It is based on the collection of clinical, laboratory and therapy data on databases of patients affected by Vernal keratoconjunctivitis.
Participation in the study will be proposed to parents of patients with VKC over 10 years of age at puberty (B2 according to Tanner for females and G2 according to Tanner for males), based on endocrinological evaluation. Patients, differentiated by gender, will be divided into two groups: patients with active VKC and patients with resolved VKC. Both study groups will be offered a blood sample to determine the serum levels of LH, FSH, estradiol, DHEAS, androstenedione, total testosterone, SHBG, DHT, 17OH-progesterone, TSH-R, albumin, ACTH and cortisol. In postpuberal females, the sample must be taken in the first 5 days of the menstrual cycle.
This study provides for the enrollment of patients diagnosed with VKC followed at the Allergy Outpatient Clinic of the UOSD Pediatrics High Intensity of Care - IRCCS Ca 'Granda Foundation Ospedale Maggiore Policlinico di Milano. The source documentation of the data will be the medical record and the reports of the examinations, provided for by the study, performed at the Institute. On the same day, a blood sample and a pubertal stage assessment will be performed. An allergy / ophthalmological examination for VKC will be carried out only if it had not been performed in the 12 months prior to the execution of the blood sample. There is no follow-up.
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
- 10 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of VKC assessed by an allergologist or ophthalmologist over 10 years of age
排除标准
- •Presence of pre-existing pathologies of the endocrine system.
结局指标
主要结局
To assess the difference in serum total testosterone levels between the population of subjects with active VKC and the population of subjects with resolved VKC.
时间窗: All subjects enrolled between April 2021 and October 2021 undergo a venous blood sample for the determination of plasma testosterone. This withdrawal is made in the morning, between 8.30 and 9.30 am, in a single determination at the time of enrollment.
A venous blood sample is taken from all enrolled subjects for the determination of plasma testosterone. This collection is made in the morning, between 8.30 and 9.30 am.
次要结局
- To evaluate the difference in serum levels of the other hormones investigated between the population of subjects with active VKC and the population of subjects with resolved VKC.(All subjects enrolled between April 2021 and October 2021 undergo a venous blood sample for the determination of plasma hormones. This withdrawal is made in the morning, between 8.30 and 9.30 am, in a single determination at the time of enrollment.)
- To assess the correlation between serum hormone levels and VKC activity.(All subjects enrolled between April 2021 and October 2021 undergo a venous blood sample for plasma hormones. This withdrawal is made in the morning, between 8.30 and 9.30 am, in a single determination at the time of enrollment.)
- To evaluate the possible presence of a serum hormone marker that may be related to the resolution of ocular symptoms.(All subjects enrolled between April 2021 and October 2021 undergo a venous blood sample for plasma hormones. This withdrawal is made in the morning, between 8.30 and 9.30 am, in a single determination at the time of enrollment.)