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Blood-based early detection of cancer based on multiplex biomarker analyses

Blood-based early detection of cancer based on multiplex biomarker analyses

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00016964
Enrollment
4000
Registered
2019-04-04
Start date
2018-03-26
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C50 C56 C54

Interventions

Group 1: Breast Cancer Patients - Blood draw - Urine Analysis - questionnaire Group 2: Cancer free controls

Sponsors

Universitätsklinikum Heidelberg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: ? Age > 18 years ? Sufficient knowledge of the German language ? signed declaration of consent ? no physical or mental-psychological impairment ? Capacity to consent

Exclusion criteria

Exclusion criteria: ? Age < 18 years ? Missing signed declaration of consent ? Physical or mental-psychological impairment that makes it impossible to answer questionnaires ? Insufficient knowledge of the German language

Design outcomes

Primary

MeasureTime frame
Development of a prediction model for breast cancer (compared to the gold standard).

Secondary

MeasureTime frame
1. In addition, the following sub questions are to be answered: a. Are there tumor type-specific marker constellations? b. Do the additional, newly detected, blood-based, measurable markers have an added value to the marker constellation described so far and improve the algorithm? c. Is it possible to detect markers from urine as possible marker constellations? d. Which marker values distinguish other tumor diseases or other benign findings from BC disease? e. How are the markers to be detected in long-term survivors, i.e. women 5 years after cancer, without detectable current tumor manifestation? f. What are the marker signatures like in metastasized women? g. Which laboratory protocols can be established to simplify these measurements? h. How do the marker constellations in the blood differ from the expression in the tissue of the same patient? 2. Can our markers be measured in multiplex assays? 3. Evaluation of the possibility of predicting the long-term course of a breast cancer as well as the development of the biomarker composition in the long-term course on the basis of follow-up blood samples. 4. Secondary objective: asservation of blood and urine samples for the establishment of a biobank for further questions which may contribute to the optimization of the diagnosis and therapy of cancer.

Countries

Germany

Contacts

Public ContactSarah Schott

Universitätsfrauenklinik

Sarah.Schott@med.uni-heidelberg.de0622156706

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026