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ACTIVE NOT RECRUITING
NCT05410951

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

Sponsor: European Institute of Oncology

View on ClinicalTrials.gov

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

Key Details

Gender

FEMALE

Age Range

18 Years - 99 Years

Study Type

OBSERVATIONAL

Enrollment

800

Start Date

2022-05-16

Completion Date

2026-05-16

Last Updated

2025-12-04

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Illumina panel

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

Locations (1)

European Institute of Oncology

Milan, Italy