Development of a Horizontal Data Integration Classifier for Noninvasive Early Diagnosis of Breast Cancer

Summary

This is a translational no-profit study. Our proposal aims at creating a noninvasive Horizontal Data Integration (HDI) classifier for early diagnosis of breast cancer, with the final goal of avoiding in most cases useless biopsies of suspect cases encountered during radiological screening.

Women with radiologically identified lesions, BIRADS-3/4/5, smaller than 2 cm by radiological assessment (i.e., radiological T1), will be enrolled and invited to donate peripheral blood samples (35 ml) and urine samples (50 ml). Radiological images as well as demographic and anatomopathological data will be collected.

Objective of this project is to develop a HDI classifier enabling early noninvasive diagnosis of breast cancer with similar accuracy compared to breast biopsies. Such classifier will be developed based on the correlation between the molecular profile of peripheral blood (ctDNA, proteins, exosomes) and urine (ctDNA) collected at T0 (baseline, before diagnostic biopsy) and bioptic diagnosis. The assessment of the profile of peripheral blood (ctDNA, proteins, exosomes) and urine (ctDNA) at two time points for diagnosed pT1 breast cancers (T0: baseline, before biopsy; T1: after diagnosis of pT1 breast cancer) will allow us to distinguish between tumor- and host-specific molecular alterations in connection with the presence/absence of breast cancer.

Conditions

• Breast Cancer

Interventions

DIAGNOSTIC_TEST

Blood and urine molecular analysis (Timing 0)

peripheral blood and urine sample collection

DIAGNOSTIC_TEST

Blood and urine molecular analysis (Timing 1)

peripheral blood and urine sample collection

Sponsors & Collaborators

• Associazione Italiana per la Ricerca sul Cancro

  collaborator OTHER

• Universita degli Studi di Genova

  collaborator OTHER

• Sidra Medicine

  collaborator OTHER

• Dana-Farber Cancer Institute

  collaborator OTHER

• Ospedale Policlinico San Martino

  lead OTHER

Principal Investigators

• Gabriele Zoppoli, MD, PhD · Ospedale Policlinico San Martino

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-01-19

Primary Completion

2023-12-31

Completion

2024-12-31

Countries

• Italy

Study Locations