Fenotipado Molecular De Pacientes Con Migraña Según Edad Y Sexo a Través De La Cuantificación De CGRP En Saliva Para Realizar Medicina De Precisión: Estudio FAST
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- CGRP level
研究概览
简要总结
Patients will be asked to visit the study center 2 times, the first time for clinical assessment and a second time for sample collection. Healthy controls will only be asked to visit the study center for sample collection. A sample of blood and saliva will be collected in order to measure CGRP levels and DNA and hormone testing.
详细描述
CGRP is a neuropeptide related to migraine pathophysiology, which can be found in human saliva in both patients and healthy controls. The differences in CGRP levels may help us explain the differences in the treatment response.
A sample of saliva will be collected in order to measure CGRP levels and a blood sample will be collected in order to conduct a DNA test and hormones test.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Migraine patients according to ICHD-3 criteria
- •Healthy controls paired to patient age and sex, without headache and without first degree family history of headache.
排除标准
- •Presence of any major medical or neurological illness.
- •Presence of any salivary gland malfunction.
- •Abuse or dependence to tobacco, alcohol or any drug in the previous 12 months before the enrollment.
- •Active migraine preventive treatment.
- •Pregnant or breastfeeding female.
结局指标
主要结局
CGRP level
时间窗: Through study completion, an average of 1 year
Measure of CGRP in saliva
Hormone levels
时间窗: Through study completion, an average of 1 year
Blood test to quantify female hormones (FSH, LH, estradiol, progesterone, prolactin) and male hormones (testosterone) in all participants except for prepubertal children.
DNA test
时间窗: Through study completion, an average of 1 year
DNA testing for CGRP or its receptor related genes (CALCA, CALCB, CALCRL and RAMP1)
次要结局
未报告次要终点