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

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.

Conditions

• Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Interventions

DIAGNOSTIC_TEST

Validation of Prognostic tool

Collection of Clinical History: Clinical data, including medical history, clinicopathological features (e.g., age, histology, receptor and nodal status), and follow-up information (presence or absence of metastasis, patient vital status), will be collected and entered into a dedicated platform by. Follow-up updates are scheduled by Month 48 of the project (December 31, 2025) to ensure timely and accurate patient outcome data. Laboratory Analysis: Residual tumor sections prepared by the Pathology Unit of each participating center will be sent to the Oncology Laboratory at CSS-IRCCS, where RNA will be extracted using standardized experimental procedures. Expression levels of miR-3916, miR-3613-5p, and their target genes will be analyzed by quantitative real-time PCR (RT-qPCR). Protein expression of target genes will be assessed via immunohistochemistry. Additionally, the extracted RNA will be analyzed at the Gerobiomics and Exposomics Laboratory of IRST IRCCS.

Sponsors & Collaborators

• Istituto Tumori Giovanni Paolo II, BARI

  collaborator UNKNOWN

• IRCCS Centro di Riferimento Oncologico della Basilicata

  collaborator OTHER

• Fondazione Humanitas per la Ricerca

  collaborator OTHER

• Fondazione IRCCS Policlinico San Matteo di Pavia

  collaborator OTHER

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

  collaborator OTHER

• Istituto Nazionale Tumori Regina Elena

  collaborator UNKNOWN

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  collaborator OTHER

• Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

  collaborator NETWORK

• Casa Sollievo della Sofferenza IRCCS

  lead OTHER

Principal Investigators

• Paola Parrella, MD · Fondazione Casa Sollievo della Sofferenza, IRCCS

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-10

Primary Completion

2026-06-30

Completion

2026-12-31

Countries

• Italy

Study Locations