Predicting Cancer Risk With Digital and Molecular Markers

ConditionsBreast Cancer Lung Cancer Colorectal Cancer Gynecologic Cancer

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorUniversity of Erlangen-Nürnberg Medical School

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

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)

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

Biomaterial collection
Other intervention
All subjects will be asked to provide biomaterial (blood or saliva) for bio marker screening and analysis. Additional biomaterial (breath, urin, stool) is optional.
BayPass mobile application
Other intervention
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.

Treatment groups

1,250 Participants

are divided into 2 treatment groups

Group A: Case group (subjects with known pre-existing or current cancer diagnosis)Other 2 interventions

Group B: Control group (healthy subjects)Other 2 interventions

Trial outcomes

Primary outcomes

Assessment of breast cancer risk by polygenic risk score in combination with app-based self-reported health behavior in the study population

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

Time frame

Baseline

Locations

Map coordinates are unavailable for these locations. Locations are shown below instead.

DigiOnko PräventionsmobilRecruiting Please Refer to Project Homepage For Details (see Link Below), Bavaria Germany

Germany

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Erlangen-Nürnberg Medical School

Lead sponsor

University Hospital Erlangen

Sponsor institution

Source ClinicalTrials.gov

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