NCT06773598|Recruiting
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Sponsor study identifier
observational
1,100
1 country
1
Study Start
May 21, 2024
Actual (reported)Primary Completion
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this observational study is to validate a clinically significant predictive machine learning model based on the processing of images RMmp (Multiparametric Magnetic Resonance Imaging). To be validated the model should be evaluated on:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 21, 2024
Actual (reported)January 9, 2025
Actual (reported)January 14, 2025
Actual (reported)October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Specificity (SP)
Specificity is the probability of obtaining a negative classification or that the disease is indeed absent.
From enrollment to the end of treatment at 5 years
Sensitivity (SN)
Sensitivity is the probability of a positive classification or that the disease is actually present.
From enrollment to the end of treatment at 5 years
Positive Predictive Value (PPV)
It is the ratio of patients truly diagnosed as positive to all those who had positive test results (including healthy subjects who were incorrectly diagnosed as patient).
From enrollment to the end of treatment at 5 years
Negative Predictive Value (NPV)
It is the ratio of subjects truly diagnosed as negative to all those who had negative test results (including patients who were incorrectly diagnosed as healthy).
From enrollment to the end of treatment at 5 years
The study will include participants who have performed an MMR at the U.O.C. Radiology Addomino-Pelvic Diagnostic and Interventional of the IRCCS University Hospital of Bologna, Sant'Orsola Polyclinic and a TRUS biopsy with fusion technique with RMmp of the prostate. The retrospective enrollment refers to the period between 15 September 2015 (date start of TRUS biopsy with fusion technique with RMmp at the Policlinico di Sant'Orsola) and the date of approval of this study. The prospective enrollment refers to the period of time from the study approval until the following 3 years.
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138, Italy
Caterina Gaudiano, MD
IRCCS Azienda Ospedaliero-Universitaria di Bologna
First Submitted
January 9, 2025
First Posted
January 14, 2025
Study Start
May 21, 2024
Actual (reported)Primary Completion
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Feasibility of Day-surgery Management for Patients Undergoing Robotic Radical Prostatectomy: a Randomized Trial
Contact the study team to confirm eligibility.
Study Completion
November 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 14, 2025
Record last verified: 2024-11
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Source: ClinicalTrials.gov.
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