Clinical Study Evaluating Targeted Biopsies and Cytological Imprints in Prostate Cancer
NCT ID: NCT01745718
Last Updated: 2015-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2012-10-31
2013-09-30
Brief Summary
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It is useful to know whether the biopsy is cancer or not, in order to know when to stop sampling and when to continue.
The strategy is used in other types of cancer, e.g lung, breast etc
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Detailed Description
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When 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.
Aim:
The correlation between cytological imprints and histology of targeted prostate biopsies
Material\&Method:
All patients in this study are already participating in an ongoing randomized biopsy study (NCT01455792) comparing:
1. Preoperative MRI and targeted biopsies + random biopsies .
2. Random biopsies (gold standard).
Only patients with a positive MRI were included in this collateral study.
The cytological imprints (negative/positive) of each targeted biopsy is compared to the histology (negative/positive) and Gleason score.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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MRI and targeted biopsies
All patients receive the same level/number of diagnostic procedures. They all undergo targeted biopsies which are compared to the cytological imprints.
Cytological imprints
Each targeted biopsy is subject to cytological imprints. It causes no extra biopsies or extra discomfort for the patients
Interventions
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Cytological imprints
Each targeted biopsy is subject to cytological imprints. It causes no extra biopsies or extra discomfort for the patients
Eligibility Criteria
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Inclusion Criteria
* No previous prostate biopsies
* Positive MRI
* Signed letter of informed concent
Exclusion Criteria
* Previous prostate biopsies
MALE
No
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Principal Investigators
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Eduard Baco, MD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
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Oslo University Hospital , Aker
Oslo, , Norway
Countries
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Other Identifiers
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OsloUH_2
Identifier Type: -
Identifier Source: org_study_id
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