Clinical Trial

Validation of a Prognostic Method for Assessing the Risk of Distant Metastasis in Early-stage Breast Cancer

Study acronym: PORTENT
Enrolling by Invitation
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Record status
This record was last updated January 30, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a multicenter, observational validation study designed to evaluate the prognostic performance of the PORTENT algorithm in patients with early-stage breast cancer. The model integrates clinicopathological variables and the expression levels of two small non-coding RNAs (miR-3916 and miR-3613-5p) to estimate individual risk of developing distant metastases. The primary objective is to assess the discriminatory ability of the PORTENT algorithm for predicting distant metastasis at predefined time points after diagnosis.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-19.
Trial Details
NCT Number NCT07372261
Lead Sponsor Casa Sollievo della Sofferenza IRCCS
Collaborators: Istituti Tumori Giovanni Paolo II, IRCCS Centro di Riferimento Oncologico della Basilicata, Fondazione Humanitas per la Ricerca, Fondazione IRCCS Policlinico San Matteo di Pavia, Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS, Istituto Nazionale Tumori Regina Elena, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Conditions Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Enrollment 1,000 participants
Start Date 2022-03-10
Primary Completion 2026-06 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-30