Predicting Cancer Risk With Digital and Molecular Markers (PräDigt)

University of Erlangen-Nürnberg Medical School

Status: Enrolling

Conditions: Breast Cancer; Gynecologic Cancer; Lung Cancer; Colorectal Cancer

Treatments: Other: BayPass mobile application; Other: Biomaterial collection

Study type: Interventional

Funder types: Other

Identifiers

NCT06962670

PräDigt-08/22

Details and patient eligibility

About

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.

Enrollment: 1,250 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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1,250 participants in 2 patient groups

Case group (subjects with known pre-existing or current cancer diagnosis)

Other group

Description:

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

Treatment:

Other: BayPass mobile application

Other: Biomaterial collection

Control group (healthy subjects)

Other group

Description:

The control group will consist of healthy subjects with no history of cancer

Treatment:

Other: BayPass mobile application

Other: Biomaterial collection