Persistent Organic Pollutants and Breast Cancers (POPCASE)

NCT02890095 | Active Not Recruiting

• 1 other identifier: ICO-N-2014-08
• Study Type: interventional
• Target: 769
• Locations: 1 country
• Sites: 3

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).

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• correlation between the individual risk of breast cancer and persistent chemical contaminants

  The main objective is to establish a correlation between the individual risk of breast cancer and persistent chemical contaminants (POPs) respectively measured in adipose tissue (i.e. storage compartment) and blood (i.e. circulating compartment). =\> Comparison of the assay in the body of a set of chemical pollutants in the environment between the following two groups: * Group A: women receiving breast cancer surgery, * Group B: women receiving breast surgery for the purpose of plastic surgery (control) This contamination profile is "exposure of interest" in this study. The quantification of this exposure is based on a targeted measure, by mass spectrometry, an expanded set of representative substances of the main families of lipophilic POPs (pesticides, PCBs, dioxins and polybrominated compounds) present to trace (femtomol).

  10 years after surgery

Study Arms (2)

Arm A = Breast Cancer surgery

EXPERIMENTAL

Arm A : women undergoing breast cancer surgery.

Procedure: Breast cancer surgery

Arm B = Control (plastic surgery)

OTHER

Arm B : women undergoing breast surgery for the purpose of plastic surgery

Procedure: plastic surgery

Interventions

Breast cancer surgery PROCEDURE

First, 2 specific adipose tissue samples will be performed during the surgery : * 1 sample near the tumor, to measure the contaminants (dioxins, PCBs, organochlorine pesticides, polybrominated compounds) * 1 remote sample of the tumor bed, superficial, at least 5 cm from the tumor, to be used to determine the level of expression of hormone receptors and to establish the expression profiles, after cutting and inclusion in paraffin blocks for marking IHC. These withdrawals are made during surgery, during surgery, as part of the intervention and the remodeling of the mammary gland (standard care for patients). This is unused balance for diagnostic. Before anaesthesia : specific blood samples (for the determination of circulating pollutants and for the analysis of gene polymorphism)

Arm A = Breast Cancer surgery

plastic surgery PROCEDURE

The excision piece will follow the classical pathological circuit. A specific charge of subcutaneous adipose tissue will be performed as part of research on the surgical specimen. This sample will be used: * measuring contaminants (dioxins, PCBs, organochlorine pesticides, polybrominated compounds) * to determine the level of expression of hormone receptors and to establish the expression profiles, after cutting and inclusion in paraffin blocks for marking IHC. These samples are all made during surgery, for usual care surgery these patients. Before anaesthesia : specific blood samples (for the determination of circulating pollutants and for the analysis of gene polymorphism)

Arm B = Control (plastic surgery)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women ≥ 18 and \<75 years
• According to the arm:
• Arm B: Any woman operated on for breast plastic surgery (breast lift and breast reduction cure only)
• Performance status (WHO) ≤ 1
• \. 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

You may not qualify if:

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

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (3)

Clinique Breteche

Nantes, 44046, France

Location

ICO René Gauducheau

Saint-Herblain, 44805, France

Location

Gustave Roussy

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Plastic Surgery Procedures

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Mario CAMPONE, MD, PhD

  Institut de Cancérologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 7, 2016
• Study Start: January 1, 2016
• Primary Completion: June 5, 2024
• Study Completion (Estimated): June 1, 2034
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)