Predicting Cancer Risk With Digital and Molecular Markers

NCT06962670 | Recruiting

• 1 other identifier: PräDigt-08/22
• Study Type: interventional
• Target: 1,250
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Lung Cancer; Colorectal Cancer; Gynecologic Cancer

Outcome Measures

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

  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

Study Arms (2)

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

OTHER

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; Other: BayPass mobile application

Control group (healthy subjects)

OTHER

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

Other: Biomaterial collection; Other: BayPass mobile application

Interventions

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.

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

DigiOnko Präventionsmobil

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

RECRUITING

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Matthias W. Beckmann, Prof. Dr. med.

  Head of Department of Obstetrics and Gynecology

  STUDY DIRECTOR

Central Study Contacts

Peter A. Fasching, Prof. Dr. med.

CONTACT

+49 9131 85 33572; fk-digionko@uk-erlangen.de

Hanna Hübner, PD Dr. rer. nat.

CONTACT

fk-digionko@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: May 8, 2025
• Study Start: September 14, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)