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NCT06773598Recruiting

Validation of a Machine Learning Model Based on MR for the Prediction of Prostate Cancer

Validation of a Machine Learning Model Based on Multiparametric MR for the Prediction of Clinically Significant Prostate Cancer

Source: ClinicalTrials.gov · Last updated 14 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Observational
Enrollment
1100 (estimated)
First submitted
9 Jan 2025
Start date
21 May 2024
Primary completion date
Oct 2028
Lead sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
NCT number
NCT06773598

What you commit to

  • Study type: Observational
  • Planned participants: 1100
  • From 21 May 2024 to the primary completion date, Oct 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous prostate surgery or hormone therapy

Other

  • Technically sub-optimal investigations for the presence of artifacts (hip prosthesis, movement of the endorectal probe, etc.)

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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BolognaItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.