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Clinical Study Evaluating Targeted Biopsies and Cytological Imprints in Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01745718
Recruitment Status : Withdrawn (The study was stopped for technical reasons)
First Posted : December 10, 2012
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE November 20, 2012
First Posted Date  ICMJE December 10, 2012
Last Update Posted Date September 23, 2015
Study Start Date  ICMJE October 2012
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2012)
Interobserver variability [ Time Frame: 15 months ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 7, 2012)
The detection rate of high grade cancer [ Time Frame: 15 months ]
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).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Clinical Study Evaluating Targeted Biopsies and Cytological Imprints in Prostate Cancer
Official Title  ICMJE Targeted Biopsies and the Role of Cytological Imprints for Diagnosis of Prostate Cancer
Brief Summary

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

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:

  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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Other: Cytological imprints
Each targeted biopsy is subject to cytological imprints. It causes no extra biopsies or extra discomfort for the patients
Study Arms  ICMJE 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.
Intervention: Other: Cytological imprints
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 22, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2012)
100
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01745718
Other Study ID Numbers  ICMJE OsloUH_2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eduard Baco, MD Oslo University Hospital
PRS Account Oslo University Hospital
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP