Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma
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|ClinicalTrials.gov Identifier: NCT00400894|
Recruitment Status : Unknown
Verified February 2007 by ProteoSys AG.
Recruitment status was: Active, not recruiting
First Posted : November 17, 2006
Last Update Posted : February 5, 2007
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:
- ANXA3 can be detected in urine after standard digital rectal examination.
- ANXA3 has better specificities than tPSA, in particular in the grey zone of PSA
- ANXA3 can help avoid unnecessary biopsies
- ANXA3 can in the long run replace PSA as a marker
|Condition or disease|
|Prostate Cancer Benign Prostatic Hyperplasia Prostatic Intraepithelial Neoplasia|
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:
• Can annexin A3 provide a better specificity than tPSA, in particular in the grey zone of PSA (2-10 ng/ml) and can annexin A3 thus contribute to a significant reduction of invasive transrectal biopsies?
|Study Type :||Observational|
|Estimated Enrollment :||750 participants|
|Observational Model:||Defined Population|
|Official Title:||Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma|
|Study Start Date :||September 2005|
|Estimated Study Completion Date :||September 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400894
|Principal Investigator:||Martin Schostak, PD Dr.||University Medical Centre Charité, Berlin, Germany|
|Study Director:||André Schrattenholz, Prof. Dr.||ProteoSys AG, Mainz, Germany|