Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:48 AM
Study NCT ID:
NCT00400894
Status:
UNKNOWN
Last Update Posted:
2007-02-05
First Post:
2006-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D011470', 'term': 'Prostatic Hyperplasia'}, {'id': 'D019048', 'term': 'Prostatic Intraepithelial Neoplasia'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'DEFINED_POPULATION'}, 'enrollmentInfo': {'count': 750}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-02', 'completionDateStruct': {'date': '2006-09'}, 'lastUpdateSubmitDate': '2007-02-02', 'studyFirstSubmitDate': '2006-11-16', 'studyFirstSubmitQcDate': '2006-11-16', 'lastUpdatePostDateStruct': {'date': '2007-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-17', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['prostate cancer', 'annexin A3', 'early detection', 'exprimate urine'], 'conditions': ['Prostate Cancer', 'Benign Prostatic Hyperplasia', 'Prostatic Intraepithelial Neoplasia']}, 'referencesModule': {'references': [{'pmid': '17205602', 'type': 'BACKGROUND', 'citation': 'Wozny W, Schroer K, Schwall GP, Poznanovic S, Stegmann W, Dietz K, Rogatsch H, Schaefer G, Huebl H, Klocker H, Schrattenholz A, Cahill MA. Differential radioactive quantification of protein abundance ratios between benign and malignant prostate tissues: cancer association of annexin A3. Proteomics. 2007 Jan;7(2):313-22. doi: 10.1002/pmic.200600646.'}, {'pmid': '19012935', 'type': 'DERIVED', 'citation': 'Schostak M, Schwall GP, Poznanovic S, Groebe K, Muller M, Messinger D, Miller K, Krause H, Pelzer A, Horninger W, Klocker H, Hennenlotter J, Feyerabend S, Stenzl A, Schrattenholz A. Annexin A3 in urine: a highly specific noninvasive marker for prostate cancer early detection. J Urol. 2009 Jan;181(1):343-53. doi: 10.1016/j.juro.2008.08.119. Epub 2008 Nov 13.'}]}, 'descriptionModule': {'briefSummary': '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:\n\n* ANXA3 can be detected in urine after standard digital rectal examination.\n* ANXA3 has better specificities than tPSA, in particular in the grey zone of PSA\n* ANXA3 can help avoid unnecessary biopsies\n* ANXA3 can in the long run replace PSA as a marker', 'detailedDescription': '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.\n\nPatients (500-750) were (and are) continuously recruited from four clinical centres in Germany (Berlin, Tübingen, Ludwigshafen) and Austria (Innsbruck). The major aspect was:\n\n• 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?'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a histological confirmation of adenocarcinoma of the prostate\n* Patients with benign prostatic hyperplasia (confirmed by histology of lance biopsies or TUR-P)\n\nExclusion Criteria:\n\n* Patients with rectal extirpation\n* Patients with renal or bladder tumors'}, 'identificationModule': {'nctId': 'NCT00400894', 'briefTitle': 'Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'ProteoSys AG'}, 'officialTitle': 'Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma', 'orgStudyIdInfo': {'id': 'EA 4/033/06'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Martin Schostak, PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Centre Charité, Berlin, Germany'}, {'name': 'André Schrattenholz, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ProteoSys AG, Mainz, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ProteoSys AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, {'name': 'Medical Centre, Ludwigshafen, Germany', 'class': 'UNKNOWN'}, {'name': 'Medical University Innsbruck', 'class': 'OTHER'}]}}}