MedTrace Logo

LobularCard Trial: Searching for Novel Germline Mutations in Lobular Breast Cancer Patients

NCT05410951 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2025-12-04

No results posted yet for this study

Summary

This is a cross-sectional and retrospective study of a cohort of patients with invasive lobular breast cancer (LBC) or in situ lobular neoplasia (LIN3).

The main endpoint is the relative frequency of patients with a germline mutation using a recent panel including 113 genes from the "Illumina" protocol.

In case of identification of a novel pathogenetic germline mutations, a personalized follow-up will be offered to each patient (in case of genes at moderate-, low-penetrance), or prophylactic mastectomy (in case of genes at high-penetrance).

Breast screening in moderate-, low-penetrance mutated patients should be performed periodically using digital mammography, ultrasound and MRI, and will be routinely observed.

Patients will be scheduled for follow-up at six-month intervals for 5 years at our outpatient clinic, and yearly thereafter

Conditions

  • Lobular Breast Carcinoma
  • Lobular in Situ Breast Carcinoma
  • BRCA1 Mutation
  • BRCA2 Mutation

Interventions

DIAGNOSTIC_TEST

Illumina panel

Determination of germline mutations using a recent panel including 113 genes from the "Illumina" protocol

Sponsors & Collaborators

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Giovanni Corso, PhD, MD · European Institute of Oncology

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-16
Primary Completion
2025-12-31
Completion
2026-05-16

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05410951 on ClinicalTrials.gov