- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01745718
Clinical Study Evaluating Targeted Biopsies and Cytological Imprints in Prostate Cancer
Targeted Biopsies and the Role of Cytological Imprints for Diagnosis of Prostate Cancer
The investigators will evaluate the accuracy of performing cytological imprints of targeted biopsies when diagnosing prostate cancer.
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
Study Overview
Detailed Description
Background:
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:
- Preoperative MRI and targeted biopsies + random biopsies .
- 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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Oslo, Norway, 0514
- Oslo University Hospital , Aker
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Prostate specific antigene (PSA) 4-20ng/ml, and/or abnormal digital rectal examination
- No previous prostate biopsies
- Positive MRI
- Signed letter of informed concent
Exclusion Criteria:
- Contraindications to MRI
- Previous prostate biopsies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
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Each targeted biopsy is subject to cytological imprints.
It causes no extra biopsies or extra discomfort for the patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The rate of positive and negative cytological imprints, e.g presence of malignant cells or not.
Time Frame: 15 months
|
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.
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15 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interobserver variability
Time Frame: 15 months
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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.
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15 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The detection rate of high grade cancer
Time Frame: 15 months
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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).
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15 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eduard Baco, MD, Oslo University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OsloUH_2
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