Breast Cancer, Colorectal Cancer, Gynecologic Cancer, Lung Cancer
Conditions
Brief summary
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.
Interventions
OTHERBiomaterial collection
All subjects will be asked to provide biomaterial (blood or saliva) for bio marker screening and analysis. Additional biomaterial (breath, urin, stool) is optional.
OTHERBayPass mobile application
All subjects will be asked to use the study-specific mobile application BayPass to complete questionnaires and provide results from screening examinations over a course of 12 months.
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Biological adult (at least 18 years old) women 2. Written informed consent for study participation and processing of personal data 3. Own smartphone that can run the BayPass mobile application and willingness to use said smartphone for study purposes Additional inclusion criterion for case group: 4. 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)
Exclusion criteria
1. 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 2. Acute severe or potentially life-threatening illness, except those specified in inclusion criterion #4
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of breast cancer risk by polygenic risk score in combination with app-based self-reported health behavior in the study population | 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 |
Countries
Germany
Contacts
Primary ContactPeter A. Fasching, Prof. Dr. med.
Backup ContactHanna Hübner, PD Dr. rer. nat.
Outcome results
None listed