A Case-control Study of the Molecular Genetics of Menstrual Migraine (Pure Menstrual and Menstrually-related Migraine)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 585
- 试验地点
- 1
- 主要终点
- Progesterone Receptor Gene Polymorphism PROGINS in Women With Menstrual Migraine and Women Without Migraine
研究概览
简要总结
The investigators hypothesize that genes that play a role in menstrual migraine can be identified using a well characterised migraine population and a comprehensive genome-wide association scan approach.
The aim of the study is to identify genes, genetic regions, and the effect of hormones on expression profiles in women with menstrual migraine compared to a control population with no personal or first-degree family history of migraine.
In this case control study, saliva samples will be taken from 300 cases and 300 controls for DNA analysis. Blood samples from 30 cases and 30 controls will be taken during the follicular phase as well as the luteal phase of the menstrual cycle for ribonucleic acid (RNA) analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All cases and controls must:
- •Be over 18 years
- •Caucasian
- •Provide written, informed consent
- •Clearly understand and be able to comply with all the trial procedures, as required
- •Not have taken part in trials of any investigational products within the previous 4 weeks
- •Cases must have at least a 12-month current or past history of menstrual migraine
- •Cases must have at least a 12-month current history of menstrual migraine
- •Cases must have kept at least three months of headache diary data in advance of visit in order to confirm diagnosis
- •Controls must still be having menstrual periods
排除标准
- •Cases and controls must not have smoked, chewed gum or consumed any food or drink in the 30 minutes prior to sample collection
- •Cases and controls will not be eligible for participation if they have:
- •Polycystic ovarian syndrome;
- •Taken any hormones or drugs in the previous three months that may affect normal hormone activity (e.g., hormonal contraceptives, hormone replacement therapy, dietary supplements such as isoflavones);
- •Donated or lost a significant amount of blood (> 550 mL) within the previous 12 weeks
- •Additionally, controls must not have a personal or family history in any first-degree relative of current or past migraine
结局指标
主要结局
Progesterone Receptor Gene Polymorphism PROGINS in Women With Menstrual Migraine and Women Without Migraine
时间窗: 6 years
PR PROGINS
Estrogen Receptor 1 G594a Polymorphism in Women With Menstrual Migraine and Women Without Migraine
时间窗: 6 years
ESR1 G594A
Menstrual Cycle Expression of PGR and ESR in Women With Menstrual Migraine and Women Without Migraine
时间窗: 6 years
PgR and ESR
Estrogen Receptor 1 C325G Polymorphism in Women With Menstrual Migraine and Women Without Migraine
时间窗: 6 years
ESR1 C325G
次要结局
- Menstrual Cycle Expression of TNF and SYNE1 in Women With Menstrual Migraine and Women Without Migraine(6 years)
- SYNE1 Genotype in Women With Menstrual Migraine and Women Without Migraine(6 years)
- Tumour Necrosis Factor Genotype in Women With Menstrual Migraine and Women Without Migraine(6 years)
研究者
Dr E Anne MacGregor
Professor E Anne MacGregor
Queen Mary University of London