Endocrine Disruptors and Life STILe in Breast Cancer Development

NCT05748353 | Active Not Recruiting

• 1 other identifier: 4472
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer; BRCA1 Mutation; BRCA2 Mutation; Ovarian Cancer; Life Style; Cadmium Exposure

Outcome Measures

Primary Outcomes (1)

• Adherence to mediterranean diet

  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.

  10 years

Secondary Outcomes (2)

• Assessment of fisical activity

  10 years

• Assessment of smoke habits

  10 years

Study Arms (2)

Patients with BRCA pathological variants with breast or ovarian cancers

Patient with pathogenetic mutation of BRCA 1 or 2 gene who have developed breast or ovarian neoplasm

Patients with BRCA pathological variants without diagnosis of cancer

Patient with pathogenetic mutation of BRCA 1 or 2 gene without diagnosis of malignancy and without prophylactic surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with pathogenic mutation of BRCA1 or BRCA2 gene with/without development of BC and/or OC

You may qualify if:

• 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

You may not qualify if:

• Prophylactic breast or ovarian surgery
• Germinal variant of BRCA1 or BRCA2, class 1,2, 3.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Alessandra Fabi

Roma, 00164, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Alessandra Fabi

  Medicina di precisione in senologia, policliclinico A. Gemelli - IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Director of Unit of Precision Medicine in Breast Cancer

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: February 28, 2023
• Study Start: January 1, 2012
• Primary Completion: June 15, 2024
• Study Completion: July 15, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

IT (1)