Trial document

This trial has been registered retrospectively.
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Trial Description

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

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Trial Acronym


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URL of the Trial


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Brief Summary in Lay Language

The aim of this study is to find new biomarkers circulating in the blood or present in urine in order to improve the detection and treatment of tumor diseases in everyday clinical practice.

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Brief Summary in Scientific Language

Gynecological tumor diseases are among the most common and most aggressive cancers. Breast cancer is the world's most common female cancer entity with around 74,000 new cases annually in Germany. According to the latest data from the Federal Statistical Office, it is the fourth most common cause of death in women with around 18,000 (and 150 male) deaths annually. In recent years, an increasing annual incidence of new cases has been observed with decreasing mortality. With early detection, long-term survival of up to 95% of patients can now be achieved. At the moment, mammography screening is considered the "gold standard" for early detection of breast cancer. This method has its limitations and is not very meaningful, e.g. for dense breast tissue. A simple laboratory examination could not only extend the diagnosis, but also make the detection of a possible tumor disease more objective and simpler in addition to the conventional methods. Especially in difficult diagnostic situations, this could be used as a more sensitive and specific additional parameter for diagnosing cancer.
Currently, tumour markers are rarely used in primary diagnostics or follow-up and are usually too unspecific. A translational research group at the University Women's Hospital in Heidelberg has already identified promising new biomarkers in peripheral blood for breast cancer and submitted them for patenting. Specific candidates will now be further investigated and validated. In addition, the researchers will also search for biomarkers in urine as liquid biopsy method. The aim is to determine the sensitivity and specificity to benign findings of the breast and other tumour entities. In addition, it will be evaluated whether tumor type-specific statements are possible. In addition, the marker profiles will be examined in detail with regard to tumour type, stage and age. If tissue is present, the expression profile of the markers in the tissue will also be investigated and compared to blood. In addition, it is not yet clear whether these markers could be used as relapse or prognosis markers, as these promising markers need to be investigated as part of aftercare.
For this purpose, approximately 45 mL of blood (3 blood tubes) will be taken once from patients who have already contracted the disease as well as from cancer-healthy study participants after their clarification and written consent, and a sample of midstream urine will also be obtained. Patients are given the opportunity to participate in follow-up blood and urine samples (also 3 blood tubes) during follow-up and follow-up appointments. DNA, RNA and proteins are isolated from the whole blood or the blood plasma/serum and the urine in order to perform genetic, immunological, epigenetic and RNA or protein expression analyses. The samples are stored in the clinic's own pseudonymized biobank for 20 years. The blood and urine supernatants are to be used for future questions that may arise from the validation studies currently planned.

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Organizational Data

  •   DRKS00016964
  •   2019/04/04
  •   [---]*
  •   yes
  •   Approved
  •   S-046/2018, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C50 -  Malignant neoplasm of breast
  •   C56 -  Malignant neoplasm of ovary
  •   C54 -  Malignant neoplasm of corpus uteri
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Interventions/Observational Groups

  •   Breast Cancer Patients
    - Blood draw
    - Urine Analysis
    - questionnaire
  •   Cancer free controls
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  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

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

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Secondary Outcome

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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
  • Medical Center 
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  •   Actual
  •   2018/03/26
  •   4000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

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

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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

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Universitätsfrauenklinik
    • Ms.  Prof. Dr. med.  Sarah  Schott 
    • Im Neuenheimer Feld 440
    • 69120  Heidelberg
    • Germany
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    • Universitätsfrauenklinik
    • Ms.  Prof. Dr. med.  Sarah  Schott 
    • Im Neuenheimer Feld 440
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.