Clinical trial · Observational
LobularCard Trial: Searching for Novel Germline Mutations in Lobular Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA1 Mutation | — | UNRESOLVED | — |
| BRCA2 Mutation | — | UNRESOLVED | — |
| Lobular Breast Carcinoma | Breast Lobular Carcinoma | ALIAS | 0.90 |
| Lobular in Situ Breast Carcinoma | Breast Carcinoma In Situ | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Illumina panel | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Relative frequency of patients with a germline mutation
- timeFrame
- 1 month
- description
- Frequency of germline mutation status in patients with in situ (LIN3) or invasive LBC or bilateral LBC or LBC with or without family history for breast cancer
Secondary outcomes (4)
- measure
- Correlation of clinic-pathological data between genes at high-penetrance versus other genes
- timeFrame
- 1 month
- description
- correlation of clinic-pathological data between genes at high-penetrance (BRCA1/2, CDH1, PTEN, and PALB2) vs. other genes
- measure
- Prevalence of germline mutation status by clinical strata
- timeFrame
- 1 month
- description
- Prevalence of germline mutation status by early onset LBC (age \<45 years), bilateral LBC, LBC with family history for breast cancer
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion criteria: 1. All LBC observed retrospectively at the European Institute of Oncology, with a proved diagnosis of LBC (biopsy or operated) 2. Patients with blood available in biobank Exclusion criteria * Patients with a previous cancer (except skin basal cell carcinoma) * Patients with ductal or mixed BC
References
Publications (0)
Data not yet available