NCT06773598 Validation of a Machine Learning Model Based on MR for the Prediction of Prostate Cancer
| NCT ID | NCT06773598 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,100 participants |
| Start Date | 2024-05-21 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,100 participants in total. It began in 2024-05-21 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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: * Specificity (SP): is the probability of a negative test result, conditioned on the individual truly being negative * Sensitivity (SN): is the probability of a positive test result, conditioned on the individual truly being positive
Eligibility Criteria
Inclusion Criteria: * Participants aged 18 at the time of examination * Obtaining informed consent * Presence of one or more lesions classified as PI-RADSv2.1 ≥ 1 at a prostate RMmp at the IRCCS Azienda Ospedaliero-Universitaria in Bologna * Indication for TRUS biopsy by fusion technique integrated with systematic biopsy at the IRCCS Azienda Ospedaliero-Universitaria in Bologna Exclusion Criteria: * Previous prostate surgery or hormone therapy * Technically sub-optimal investigations for the presence of artifacts (hip prosthesis, movement of the endorectal probe, etc.)
Contact & Investigator
Caterina Gaudiano, MD
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT06773598 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06773598 currently recruiting?
Yes, NCT06773598 is actively recruiting participants. Contact the research team at caterina.gaudiano@aosp.bo.it for enrollment information.
Where is the NCT06773598 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06773598 clinical trial?
NCT06773598 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Caterina Gaudiano, MD at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 1,100 participants.
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