Endocrine Disruptors and Life STILe in Breast Cancer Development (STILVARCA)

April 11, 2024 updated by: FABI ALESSANDRA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Endocrine Disruptors and Life STILe in Patients Carrying BRCA Pathogenic VAriants With Breast and/or Ovarian CAncer and Women Without Neoplasm: the STILVARCA Study

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Breast cancer (BC) is the most frequent neoplasm in women; the lifetime probability of developing invasive breast cancer is estimated to be 12.8%. Ovarian cancer (OC) represents the second most common type of gynecologic neoplasm, with an incidence of about 1.5%. A sedentary lifestyle and being overweight seem to play a role in the development of these diseases; an increase in body mass index (BMI) of 5 units is correlated with a 12% increased risk of developing BC and 7-10% increased risk of developing OC. Exposure to environmental toxic factors, such as Cadmium (Cd), has also been found to play a role in the development of BC and OC. Indeed, it has been shown that Cd is involved in the pathogenesis of these neoplasms as it would act as an endocrine disruptor: through binding to the estrogen receptor it would determine its activation thereby promoting cell proliferation. Cd is released into the soil, water and air from natural sources but, most importantly, as a result of industrial processing the processing of nonferrous metals, the production of batteries and paints, the production and application of phosphate-based artificial fertilizers, the use of coal and petroleum, incineration and waste disposal. The general population may be exposed to Cd through: contaminated food and drinking water; cigarette smoking (active and passive), as tobacco leaves accumulate Cd from the soil; and inhalation of dust and fumes, especially for people living near industries that process or emit Cd. At the same time, it is well known that genetic factors are also related to the pathogenesis of BC and OC. In about 20% of patients with triple-negative BC and 20-25% of women with high-grade serous OC, a pathogenetic variant of these genes can be found. In subjects carrying constitutional pathogenetic variants (VPs) in the BRCA1/2 (BRCA1/2m) genes, the absence of repair of damage to the DNA double helix causes its accumulation favoring the development of neoplasms. This results in individuals carrying these variants having a cumulative risk of developing BC of 72% in the case of BRCA1 and 62% in the case of BRCA2. With regard to OC, the risk associated with the presence of VP in the case of BRCA1 is 44% and 17% in the case of BRCA2. These observations are consistent with the hypothesis that genetic risk related to cancer development is modified by environmental or other molecular factors. Several studies have evaluated factors such as lifestyle, overweight, weight gain, and physical inactivity as potential risk elements of BC or OC in BRCA1/2m mutation carriers. The aim of this study is to evaluate the possible interference of environmental factors in the development of BC or OC in women VP carriers of BRCA 1 and BRCA 2

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
275

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Roma, Italy, 00164
        • Alessandra Fabi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adherence to mediterranean diet
Time Frame: 10 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of fisical activity
Time Frame: 10 years
Assessment of physical activity (assessed through the IPAQ questionnaire). Questionnaire measures the type and amount of physical activity performed by the subject during the week and it is divided into intense, moderate and light. Each activity is assigned a score. A total score below 700 Met indicates inactivity of the subject, between 701 and 2519 sufficient activity, above 2520 adequate activity
10 years
Assessment of smoke habits
Time Frame: 10 years
An assessment of the subject's smoking habit. It evaluate the number of cigarettes smoked daily and years from beginning. The score is expressed by "pack-years" index.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alessandra Fabi, Medicina di precisione in senologia, policliclinico A. Gemelli - IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4472

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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