Clinical trial · Observational
Endocrine Disruptors and Life STILe in Breast Cancer Development
Endocrine Disruptors and Life STILe in Patients Carrying BRCA Pathogenic VAriants With Breast and/or Ovarian CAncer and Women Without Neoplasm: the STILVARCA Study
NCT05748353CI-TRIAL-00075971STILVARCAunknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of the study is to evaluate the role of lifestyle and environmental factors ( environmental contaminants such as Cd) on the penetrance of BRCA1/2 genes in BRCAm patients with Breast cancer and/or Ovarian cancer and in BRCAm healthy women without cancer diagnosis
Conditions
Conditions (6)
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 | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cadmium Exposure | — | UNRESOLVED | — |
| Life Style | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Patients with BRCA pathological variants with breast or ovarian cancers
- description
- Patient with pathogenetic mutation of BRCA 1 or 2 gene who have developed breast or ovarian neoplasm
- label
- Patients with BRCA pathological variants without diagnosis of cancer
- description
- Patient with pathogenetic mutation of BRCA 1 or 2 gene without diagnosis of malignancy and without prophylactic surgery
Primary outcomes (1)
- measure
- Adherence to mediterranean diet
- timeFrame
- 10 years
- description
- Identification of adherence to the Mediterranean diet assessed through the PREDIMED questionnaire, a validated 14-item Questionnaire of Mediterranean diet adherence. The score can range from 0 to 14. A score less than 5 indicates poor adherence to the Mediterranean diet; a score between 6 and 9 means average adherence and greater than 10 good adherence.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age\>18 years * Histologic diagnosis of early-stage BC (stage I, II, III operated; luminal, HER2+, triple-negative tumors) or OC (high-grade epithelial any stage and histotype); presence of germline variant of BRCA1 or BRCA2, class 4 or 5 * Patients carrying germline variant of BRCA1 or BRCA2, class 4 or 5, in the absence of BC and/or OC, who have not undergone prophylactic mastectomy and/or bilateral ovariectomy surgery. * Patients with malignancy must have undergone surgery and be currently disease-free or in complete or partial remission in the case of OC. * Adjuvant/neoadjuvant systemic therapy as well as maintenance therapy (PARP-inhibitors for example) is permitted. * Signature of informed consent. * ECOG: 0.1. * Compliance with questionnaire completion Exclusion Criteria: * Prophylactic breast or ovarian surgery * Germinal variant of BRCA1 or BRCA2, class 1,2, 3.
References
Publications (0)
Data not yet available
No reference posted for this study.