Predicting Cancer Risk With Digital and Molecular Markers

Sponsor
University of Erlangen-Nürnberg Medical School
Study ID
NCT06962670
Status
Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
May 8, 2025
Start date
Sep 14, 2024
Status verified
Mar 2025
Primary completion
Sep 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
1,250 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • 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: Control group (healthy subjects)
    The control group will consist of healthy subjects with no history of cancer

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 ]

Central Contacts

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