Breast CancerPräDigtNCT06962670
Predicting Cancer Risk With Digital and Molecular Markers
A study testing Biomaterial collection and BayPass mobile application in people with Breast Cancer and Lung Cancer, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Lung Cancer, Colorectal Cancer
- What is being tested?
- Biomaterial collection and BayPass mobile application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,250 participants
- Where
- 1 siteGermany
- Study dates
- 14 Sep 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hanna Hübner, PD Dr. rer. nat. contact
Germany1 site, 1 recruiting
- Recruiting
DigiOnko Präventionsmobil
Please Refer to Project Homepage For Details (see Link Below), Bavaria
Hanna Hübner, PD Dr. rer. nat. med. habil., +49 9131 8533572, fk-digionko@uk-erlangen.de
Peter A. Fasching, Prof. Dr. med.
About this study
Official 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
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
- Being tested
- Biomaterial collection, BayPass mobile application
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomaterial collectionOther
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 applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Biomaterial collection; Other: BayPass mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start14 Sep 2024
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter A. Fasching, University Hospital Erlangen
- Investigators
- Matthias W. Beckmann, Prof. Dr. med., Study director, Head of Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962670
- Sponsor's protocol ID
- PräDigt-08/22
- Acronym
- PräDigt
- Status last verified
- Mar 2025
- First submitted
- 23 Aug 2023
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06962670
- Acronym / sponsor ID
- PräDigt / PräDigt-08/22
- Conditions
- Breast Cancer, Lung Cancer, Colorectal Cancer, Gynecologic Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 14 Sep 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group (subjects with known pre-existing or current cancer diagnosis) | Other | Other: Biomaterial collection, Other: BayPass mobile applicationThe 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 |
| Control group (healthy subjects) | Other | Other: Biomaterial collection, Other: BayPass mobile applicationThe control group will consist of healthy subjects with no history of cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomaterial collectionAll subjects will be asked to provide biomaterial (blood or saliva) for bio marker screening and analysis. Additional biomaterial (breath, urin, stool) is optional. | Other | Case group (subjects with known pre-existing or current cancer diagnosis), Control group (healthy subjects) |
| BayPass mobile applicationAll 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 | Case group (subjects with known pre-existing or current cancer diagnosis), Control group (healthy subjects) |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- On this project homepage you can check where the next stop of the DigiOnko Präventionsmobil will beLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hanna Hübner, PD Dr. rer. nat. contact
Matthias W. Beckmann, Prof. Dr. med. study director
Head of Department of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biomaterial collection and BayPass mobile application in people with Breast Cancer and Lung Cancer, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter A. Fasching, Prof. Dr. med. (+49 9131 85 33572, fk-digionko@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.