Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2026-02-22 @ 11:30 PM
Study NCT ID:
NCT01745718
Status:
WITHDRAWN
Last Update Posted:
2015-09-23
First Post:
2012-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study Evaluating Targeted Biopsies and Cytological Imprints in Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The study was stopped for technical reasons', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-22', 'studyFirstSubmitDate': '2012-11-20', 'studyFirstSubmitQcDate': '2012-12-07', 'lastUpdatePostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The detection rate of high grade cancer', 'timeFrame': '15 months', 'description': 'The cytology will be compared to the specific Gleason score in patients with positive histology in order to evaluate any difference in the detection rate of intermediate/high grade cancer (Gleason score 7 or higher) and low grade cancer (\\<Gleason score 6).'}], 'primaryOutcomes': [{'measure': 'The rate of positive and negative cytological imprints, e.g presence of malignant cells or not.', 'timeFrame': '15 months', 'description': 'The cytological imprints will be compared to the histology of targeted biopsies (defined as gold standard). Measure of agreement, sensitivity and specificity will be calculated.'}], 'secondaryOutcomes': [{'measure': 'Interobserver variability', 'timeFrame': '15 months', 'description': 'The cytological imprints will be evaluated by three different cytologists and classified as either negative or positive. The results will be compared to the histology which defines the gold standard. Any difference in evaluation will be assessed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prostate cancer', 'targeted biopsies', 'cytological imprints', 'histology'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The investigators will evaluate the accuracy of performing cytological imprints of targeted biopsies when diagnosing prostate cancer.\n\nIt is useful to know whether the biopsy is cancer or not, in order to know when to stop sampling and when to continue.\n\nThe strategy is used in other types of cancer, e.g lung, breast etc', 'detailedDescription': 'Background:\n\nWhen substituting a random biopsy procedure with a few targeted biopsies, it is of outmost importance to know immediately if the biopsy is positive or not. A recent study has demonstrated a high sensitivity and specificity of imprint cytology of random biopsies.\n\nAim:\n\nThe correlation between cytological imprints and histology of targeted prostate biopsies\n\nMaterial\\&Method:\n\nAll patients in this study are already participating in an ongoing randomized biopsy study (NCT01455792) comparing:\n\n1. Preoperative MRI and targeted biopsies + random biopsies .\n2. Random biopsies (gold standard).\n\nOnly patients with a positive MRI were included in this collateral study.\n\nThe cytological imprints (negative/positive) of each targeted biopsy is compared to the histology (negative/positive) and Gleason score.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prostate specific antigene (PSA) 4-20ng/ml, and/or abnormal digital rectal examination\n* No previous prostate biopsies\n* Positive MRI\n* Signed letter of informed concent\n\nExclusion Criteria:\n\n* Contraindications to MRI\n* Previous prostate biopsies'}, 'identificationModule': {'nctId': 'NCT01745718', 'briefTitle': 'Clinical Study Evaluating Targeted Biopsies and Cytological Imprints in Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Targeted Biopsies and the Role of Cytological Imprints for Diagnosis of Prostate Cancer', 'orgStudyIdInfo': {'id': 'OsloUH_2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'MRI and targeted biopsies', 'description': 'All patients receive the same level/number of diagnostic procedures. They all undergo targeted biopsies which are compared to the cytological imprints.', 'interventionNames': ['Other: Cytological imprints']}], 'interventions': [{'name': 'Cytological imprints', 'type': 'OTHER', 'description': 'Each targeted biopsy is subject to cytological imprints. It causes no extra biopsies or extra discomfort for the patients', 'armGroupLabels': ['MRI and targeted biopsies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0514', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital , Aker', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Eduard Baco, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}