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NCT Number: NCT06962670

Predicting Cancer Risk With Digital and Molecular Markers

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.

Recruiting

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gynecologic Cancer Intestinal Diseases Intestinal Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

DigiOnko Präventionsmobil

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

Location status: Recruiting

Location contact

Hanna Hübner, PD Dr. rer. nat. med. habil.

CONTACT

[email protected]

+49 9131 8533572

Peter A. Fasching, Prof. Dr. med.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Biomaterial collection

Other

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

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.

Primary outcomes

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

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hanna Hübner, PD Dr. rer. nat.

CONTACT

[email protected]

Peter A. Fasching, Prof. Dr. med.

CONTACT

[email protected]

+49 9131 85 33572

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

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

Acronym: PräDigt

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 8, 2025
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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