Digital and Molecular Detection of Markers for Disease Risk Prediction, Improvement of Diagnostic Detection Accuracy and Implementation for Preventive Measures of Cancer - A Combined Case-control and Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,250
- 试验地点
- 1
- 主要终点
- Assessment of breast cancer risk by polygenic risk score in combination with app-based self-reported health behavior in the study population
研究概览
简要总结
The goal of this study is to identify new markers to predict the risk of developing cancer, primarily breast cancer. For this purpose, researchers will compare data obtained from cancer patients and healthy individuals. If characteristic differences are identified, e.g. in biomarkers, life style or family history, this may indicate a person's increased risk of developing cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
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
- •Biological adult (at least 18 years old) women
- •Written informed consent for study participation and processing of personal data
- •Own smartphone that can run the BayPass mobile application and willingness to use said smartphone for study purposes
- •Additional inclusion criterion for case group:
- •Pre-existing or current diagnosis of at least one of the following oncological diseases: breast cancer, lung cancer, colorectal cancer, gynecologic cancer (incl. ovarian cancer, endometrial cancer, cervical cancer, fallopian tube cancer, vaginal cancer and vulvar cancer)
排除标准
- •Known infection with HIV (Human Immunodeficiency Virus), HepA (Hepatitis A), HepB (Hepatitis B), HepC (Hepatitis C) or active SARS-CoV2 (Severe acute respiratory syndrome coronavirus type 2) infection
- •Acute severe or potentially life-threatening illness, except those specified in inclusion criterion #4
研究组 & 干预措施
Case group (subjects with known pre-existing or current cancer diagnosis)
The case group will consist of subjects with a known pre-existing or current cancer diagnosis, including breast cancer, lung cancer, colorectal cancer or gynecologic cancer
干预措施: Biomaterial collection (Other)
Case group (subjects with known pre-existing or current cancer diagnosis)
The case group will consist of subjects with a known pre-existing or current cancer diagnosis, including breast cancer, lung cancer, colorectal cancer or gynecologic cancer
干预措施: BayPass mobile application (Other)
Control group (healthy subjects)
The control group will consist of healthy subjects with no history of cancer
干预措施: Biomaterial collection (Other)
Control group (healthy subjects)
The control group will consist of healthy subjects with no history of cancer
干预措施: BayPass mobile application (Other)
结局指标
主要结局
Assessment of breast cancer risk by polygenic risk score in combination with app-based self-reported health behavior in the study population
时间窗: Baseline
Polygenic cancer risk score (PRS) as a numeric value using BOADICEA/CanRisk as absolute 10-year breast cancer risk and as relative risk compared with avarage women at the same age
次要结局
未报告次要终点
研究者
Peter A. Fasching
Prof. Dr. med.
University Hospital Erlangen