NCT02198092已完成不适用
Preliminary Evaluation of Septin9 in Patients With Hereditary Colon Cancer Syndromes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Septin9 Plasma Levels
研究概览
简要总结
This is an observational, case-control study evaluating the quantitative level of Septin9 in plasma pre- and post-colectomy in hereditary colorectal cancer (CRC) syndrome patients (Familial Adenomatous Polyposis (FAP), Lynch syndrome (also known as HNPCC), and Multiple Adenomatous Polyposis (MAP, also known as MYK/MYH) cases) and genetically related FAP-family members as controls and references.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent provided
- •Age > or = to 18 years of age
- •Patient group FAP
- •Clinical diagnosis of familial adenomatous polyposis
- •Patient group Lynch syndrome Clinical diagnosis of Lynch syndrome
- •Patient group MAP
- •Clinical diagnosis of MYH-associated polyposis and presence of more than 20 colon polyps
- •Control group (FAP)
- •Genetically related family member of patient
- •Patients: Able and willing to attend routine follow-up as advised
- •Controls, i.e. relatives of patients: Willingness to give blood at each routine follow-up as advised for the diseased relative
排除标准
- •Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV)
- •Current diagnosis of colorectal cancer
- •Pregnancy
结局指标
主要结局
Septin9 Plasma Levels
时间窗: Up to 2 years
The primary objective of the study is the observational analysis of quantitative Septin9 plasma levels over time in hereditary CRC syndrome patients pre- and post-colectomy.
次要结局
- Septin9 Plasma Levels Versus Polyps(Up to 2 years)
- Pre- and Post-Colectomy Colonic Epithelial Cell Numbers(Up to 2 years)
- Septin9 Levels Versus Circulating Colonic Epithelial Cell Numbers(Up to 2 years)
研究者
研究点 (1)
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