An interventional study of Cytological imprints in Prostate Cancer, sponsored by Oslo University Hospital. Withdrawn at 1 site in Norway. Open to male participants. Per ClinicalTrials.gov, last updated 2015-09-23.
Sponsored by Oslo University Hospital · Not applicable, Interventional, and Diagnostic
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
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:
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
Browse Prostatic Neoplasms studies →Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.
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Exclusion Criteria:
All patients receive the same level/number of diagnostic procedures. They all undergo targeted biopsies which are compared to the cytological imprints.
Other: Cytological imprints
Each targeted biopsy is subject to cytological imprints. It causes no extra biopsies or extra discomfort for the patients
The rate of positive and negative cytological imprints, e.g presence of malignant cells or not.
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.
Time frame: 15 months
Interobserver variability
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.
Time frame: 15 months
The detection rate of high grade cancer
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).
Time frame: 15 months
This study is withdrawn, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Oslo University Hospital