Clinical trial · Interventional
Clinical Study Evaluating Targeted Biopsies and Cytological Imprints in Prostate Cancer
Targeted Biopsies and the Role of Cytological Imprints for Diagnosis of Prostate Cancer
NCT01745718CI-TRIAL-00019177withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was stopped for technical reasons
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytological imprints | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- 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
Primary outcomes (1)
- 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.
Secondary outcomes (1)
- measure
- Interobserver variability
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.