Persistent Organic Pollutants and Breast Cancers (POPCASE)
Condition(s) studied
Investigational drug(s) / intervention(s)
Breast cancer surgery: 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)
plastic surgery: 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)
Study 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).
Eligibility
Primary outcome measure(s)
- correlation between the individual risk of breast cancer and persistent chemical contaminants — 10 years after surgery
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).
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Clinique Breteche | Nantes | France | |
| ICO René Gauducheau | Saint-Herblain | France | |
| Gustave Roussy | Villejuif | France |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02890095 on ClinicalTrials.gov ↗ ← All trials in France