Predicting Cancer Risk With Digital and Molecular Markers (PräDigt)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Gynecologic Cancer; Colorectal Cancer; Lung Cancer
• Intervention / Treatment: Other: Biomaterial collection; Other: BayPass mobile application

• Study Type: Interventional
• Enrollment (Estimated): 1250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter A. Fasching, Prof. Dr. med.; Phone Number: +49 9131 85 33572; Email: fk-digionko@uk-erlangen.de
• Study Contact Backup: Name: Hanna Hübner, PD Dr. rer. nat.; Email: fk-digionko@uk-erlangen.de

Study Locations

• Germany
  • Bavaria
    • Please refer to project homepage for details (see link below), Bavaria, Germany
      • Recruiting
      • DigiOnko Präventionsmobil
      • Contact: Hanna Hübner, PD Dr. rer. nat. med. habil.; Phone Number: +49 9131 8533572; Email: fk-digionko@uk-erlangen.de
      • Principal Investigator: Peter A. Fasching, Prof. Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Other: Biomaterial 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.; Other: BayPass 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.
Other: Control group (healthy subjects); The control group will consist of healthy subjects with no history of cancer	Other: Biomaterial 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.; Other: BayPass 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Investigators: Study Director: Matthias W. Beckmann, Prof. Dr. med., Head of Department of Obstetrics and Gynecology

Publications and helpful links

Helpful Links

• On this project homepage you can check where the next stop of the DigiOnko Präventionsmobil will be

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: April 29, 2025
• First Posted (Actual): May 8, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: PräDigt-08/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No