Trial document




drksid header

  DRKS00017155

Trial Description

start of 1:1-Block title

Title

Vesicular AGR2 splice-variants for non-invasive diagnostics of prostate cancer

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

VEDIPRO

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

We will conduct a clinical trial to test the contents of small urinary membrane vesicles as new biomarkers for early detection and follow-up in prostate cancer.
The meaningfulness in terms of sensitivity and specificity is examined. A combination of biomarkers will be established that will enable reliable early detection of prostate cancer. The study will be carried out at the University Hospital Freiburg.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

In the current project, we intend to conduct a clinical study that will allow us to evaluate the predictive value of AGR2-WT and AGR2 splice variants mRNA as new biomarkers for prostate cancer (PC). The study is conducted monocentrically at the Medical Center University of Freiburg. The recruitment of the intended patients will be carried out consecutively in the course of the project in order to reach the planned cohort size. In this study extracellular vesicles (EVs) from urine and blood of PC and BPH patients will be isolated. The mRNA of AGR2 and AGR2 splice variants (AGR2-SV) will be detected and quantified. In addition, 3 established PC biomarkers will be tested: the genes TMPRSS2-ERG and PSA, and a non-coding RNA sequence PCR3. The significance of AGR2, AGR2-SV, TMPRSS2-ERG, PCA3 and PSA sensitivity and specificity will be quantified by ROC analysis, compared and tested as multi-parameter biomarkers to establish a biomarker panel that provides reliable detection of PC.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00017155
  •   2019/07/31
  •   [---]*
  •   yes
  •   Approved
  •   266/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1233-7602 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   - Determination of the elevated PSA value by one of the cooperating resident urologists or by urology (Freiburg)
    - Education about the possibility of study participation
    - With consent, recording the baseline data
    - Taken blood and urine samples for the study
    - Perform MRI-assisted biopsy
    - Recording the histological findings and data from the experimental blood / urine examinations
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

1) MRI-assisted biopsy (not academic funding, but regular medical insurance)
2) Collection of the histological findings
3) Collection of data from experimental blood and urine examinations, e.g. PSA value

Based on collected data, a histological diagnosis of prostate cancer (yes / no) will be determined

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Biomarker panel for detection of prostate cancer. Primary endpoint diagnosis

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2019/09/01
  •   300
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Male
  •   45   Years
  •   75   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

PSA > 3 ng/mL

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Age > 75 years

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg, Department Chirurgie, Klinik für Urologie
    • Mr.  Dr. med.  Konrad  Wilhelm 
    • Hugstätterstr. 55
    • 79106  Freiburg im Breisgau
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Freiburg, Institut für Infektionsprävention und Krankenhaushygiene
    • Ms.  PD Dr. rer. nat.  Irina  Nazarenko 
    • Breisacherstraße 115b
    • 79106  Freiburg im Breisgau
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Freiburg, Department Chirurgie, Klinik für Urologie
    • Mr.  Dr. med.  Konrad  Wilhelm 
    • Hugstätterstr. 55
    • 79106  Freiburg im Breisgau
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bundesministerium für Wirtschaft und Energie
    • Scharnhorststr. 34-37
    • 10115  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   +49 (0)30- 18 615 0
    •   [---]*
    •   [---]*
    •   http://www.bmwi.de
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Exosomics S.p.A.
    • Mr.  Dr.  Antonio  Chiesi 
    • Via Fiorentina, 1
    • 53100  Siena
    • Italy
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.