Predicting Cancer Risk With Digital and Molecular Markers

NCT ID: NCT06962670

Last Updated: 2025-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-14

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Lung Cancer Colorectal Cancer Gynecologic Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Biomaterial collection

Intervention Type 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

Intervention Type 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.

Control group (healthy subjects)

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

Group Type OTHER

Biomaterial collection

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Peter A. Fasching

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthias W. Beckmann, Prof. Dr. med.

Role: STUDY_DIRECTOR

Head of Department of Obstetrics and Gynecology

Locations

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DigiOnko Präventionsmobil

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

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Peter A. Fasching, Prof. Dr. med.

Role: CONTACT

+49 9131 85 33572

Hanna Hübner, PD Dr. rer. nat.

Role: CONTACT

Facility Contacts

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

Role: primary

+49 9131 8533572

Related Links

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https://www.digionko-bayern.de/praeventionsmobil/

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

Other Identifiers

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PräDigt-08/22

Identifier Type: -

Identifier Source: org_study_id

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