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Sponsors and Collaborators: |
ProteoSys AG Charite University, Berlin, Germany University Hospital Tuebingen Medical Centre, Ludwigshafen, Germany Medical University Innsbruck |
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Information provided by: | ProteoSys AG |
ClinicalTrials.gov Identifier: | NCT00400894 |
Emerging from a differential proteomic study of sample pairs of prostate cancer and benign tissue, annexin A3 (ANXA3) was chosen as a potential novel biomarker for the early and non-invasive diagnosis of prostate cancer. We wanted to show or investigate, that:
Condition |
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Prostate Cancer Benign Prostatic Hyperplasia Prostatic Intraepithelial Neoplasia |
Study Type: | Observational |
Study Design: | Screening, Longitudinal, Defined Population, Retrospective/Prospective Study |
Official Title: | Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma |
Estimated Enrollment: | 750 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | September 2006 |
The aim of this multi centre and double-blinded study was to investigate specificities and sensitivities of early detection of prostate cancer with a new protein biomarker, annexin A3, using urine after digital rectal examination/massage (exprimate urine) in direct comparison to the corresponding measurements of the gold standard, total PSA. The material obtained by this non-invasive procedure was moreover used to determine appropriate cut-off values and optimal fractions (e.g. after centrifugation) and calibrations for quantitative measurements of this novel marker. Patients (500-750) were (and are) continuously recruited from four clinical centres in Germany (Berlin, Tübingen,
Ludwigshafen) and Austria (Innsbruck). The major aspect was:
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Martin Schostak, PD Dr. | University Medical Centre Charité, Berlin, Germany |
Study Director: | André Schrattenholz, Prof. Dr. | ProteoSys AG, Mainz, Germany |
Study ID Numbers: | EA 4/033/06 |
Study First Received: | November 16, 2006 |
Last Updated: | February 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00400894 History of Changes |
Health Authority: | Germany: Ethics Commission |
prostate cancer annexin A3 early detection exprimate urine |
Prostatic Intraepithelial Neoplasia Hyperplasia Prostatic Diseases Genital Neoplasms, Male Prostatic Hyperplasia Carcinoma in Situ |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms Neoplasms, Glandular and Epithelial Carcinoma |
Prostatic Intraepithelial Neoplasia Neoplasms by Histologic Type Genital Neoplasms, Male Prostatic Diseases Urogenital Neoplasms Genital Diseases, Male Carcinoma Hyperplasia |
Neoplasms Pathologic Processes Neoplasms by Site Prostatic Hyperplasia Carcinoma in Situ Prostatic Neoplasms Neoplasms, Glandular and Epithelial |