Clinical trial NCT02890095: Persistent Organic Pollutants and Breast Cancers (POPCASE)
Official title: Prospective, Multicenter, Epidemiological Case-control Study, to Establish a Possible Correlation Between Persistent Chemical Contaminants (POPs) and Breast Cancer.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 769
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Exposure to certain classes of chemical contaminants, including certain persistent organic pollutants (POPs) with a character of endocrine disruptors, could be one of the factors that lead to increase incidence of breast cancer in the Western world .

However, the causal role of POPs in the onset of breast cancer remains nowadays unproven. Preliminary epidemiological studies on the impact of these environmental factors in breast cancer etiology have ignored the critical periods of exposure. Similarly, they have considered a limited number of pollutants (not including possible joint or synergistic effects between individual compounds) and did not distinguish the different breast cancer subtypes may have different etiologies or even of genetic susceptibility factors (POP polymorphism of detoxification enzymes).

Thus, POPCASE study examines the association between the presence of breast cancer and the levels and exposure profiles to a group of POPs measured in adipose tissue (AT) and blood, in particular using spectrometric methods developed by the team LABERCA (Nantes, France). These internal levels of POPs (organochlorine pesticides, dioxins, PCBs, brominated flame retardants) will be measured both quantitatively (tissue concentrations) and qualitative (relative proportions of different pollutants sought).

Detailed description: Exposure to certain classes of chemical contaminants, including certain persistent organic pollutants (POPs) with a character of endocrine disruptors, could be one of the factors that lead to increase incidence of breast cancer in the Western world .

However, the causal role of POPs in the onset of breast cancer remains nowadays unproven. Preliminary epidemiological studies on the impact of these environmental factors in breast cancer etiology have ignored the critical periods of exposure. Similarly, they have considered a limited number of pollutants (not including possible joint or synergistic effects between individual compounds) and did not distinguish the different breast cancer subtypes may have different etiologies or even of genetic susceptibility factors (POP polymorphism of detoxification enzymes).

Finally, this demonstration has not been done for 2 reasons:

* Multidisciplinary Issues,
* Need innovative tools for statistical analysis and interpretation of these more integrated environmental data.

Thus, POPCASE study examines the association between the presence of breast cancer and the levels and exposure profiles to a group of POPs measured in adipose tissue (AT) and blood, in particular using spectrometric methods developed by the team LABERCA (Nantes, France). These internal levels of POPs (organochlorine pesticides, dioxins, PCBs, brominated flame retardants) will be measured both quantitatively (tissue concentrations) and qualitative (relative proportions of different pollutants sought).

It is therefore to improve the level of knowledge between environmental chemical exposure and increased incidence of breast cancer (in its environmental, genetic and molecular components) within the general population, in response to a public health issue, the question of the actual impact on the health of major classes of chemical pollutants present in our environment and our staying power behind debates and being associated with high stakes, both scientists but economic and societal.

Eligibility criteria: Inclusion Criteria:

1. Women ≥ 18 and \<75 years
2. According to the arm:

   * Arm A: histologically confirmed diagnosis of invasive breast cancer (only), unilateral or bilateral, outside off recurrence and relapse. Patients who have been supported for a contralateral breast cancer can be included if a period of at least 2-years between the last systemic treatment of inclusion in the study.
   * Arm B: Any woman operated on for breast plastic surgery (breast lift and breast reduction cure only)
3. Performance status (WHO) ≤ 1

5. Patient affiliated to a social security scheme, 6. Patient who signed and dated informed consent form 7. Arm A only: unifocal lesion 8. Arm A only: Clinical stage M0

Exclusion Criteria:

1. Patient with uncontrolled infection
2. Patient pregnant or lactating
3. Patient with a viral infection (HIV, Hepatitis B, Hepatitis C)
4. Patient cannot be regularly monitored for psychological reasons, social, family or geographical.
5. Patient Private of liberty or under a guardianship authority / curatorship.
6. Arm A only: Patient to benefit from neoadjuvant therapy for breast cancer
7. Arm A only Patient with metastatic breast cancer
8. Arm A only Patient diagnosed cancer in situ (intra ductal)
9. Arm A only Patient with BRCA1 or BRCA2 known
10. Arm B only: previous breast plastic surgery, regardless of the type of intervention

Primary outcomes:
measure: correlation between the individual risk of breast cancer and persistent chemical contaminants
timeFrame: 10 years after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Clinique Breteche
city: Saint-Herblain
country: France
facility: ICO René Gauducheau
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
affiliation: Institut de Cancérologie de l'Ouest
name: Mario CAMPONE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: