Persistant Organics Pollutants in Breast Cancer. (METAPOP)

Role of Persistant Organics Pollutants in the Metastatic Potential of Malignant Breast Tumor.

Persistant Organics Pollutants (POP) accumulate in the adipose tissue (AT) and could modulate tumor progression as part of the microenvironment. The investigators tested the hypothesis that POPs exposure may be associated with breast cancer metastasis analyzing the concentrations of 46 POPs in both adipose tissue and serum samples from breast tumor patients (benign, malignant with and without lymph node metastasis)

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Lymph Node Metastases; Persistant Organic Pollutants
• Intervention / Treatment: Other: Blood test sample; Other: Peritumoral adipose tissue sample

Detailed Description

The investigators set up a longitudinal prospective monocentric cohort study in the gynecologic-oncologic surgery department of European Hospital Georges-Pompidou, with patients undergoing partial or total mastectomies, lymph node biopsies or axillary lymph node removal and sampling of the adipocytic tumour microenvironment to measure POPs using gas chromatography coupled to high-resolution mass spectrometry. The objective is to analyze the concentrations of 46 POPs including polychlorinated dibenzo(p)dioxins and furans (PCDD/Fs), polychlorinated biphenyls (PCBs), polybromodiphenyl ethers (PBDEs) and polybromobiphenyls (PBBs) in both adipose tissue (AT) and serum samples from breast tumor patients (benign, malignant with and without lymph node metastasis).

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient with breast tumor: benign or malignant
• Tumor size at least 1cm or palpable tumor
• Undergoing a breast surgery in European Georges Pompidou hospital
• Understanding the protocol and who signed a written consent

Exclusion Criteria: patients unable to give informed consent

• Dementia
• Guardianship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metastatic lymph node status based of persistant organic pollutants level measured by by gas chromatography coupled to high-resolution mass spectrometry.	Correlation between 1) the concentrations of 46 persistant organic pollutants (including polychlorinated dibenzo(p)dioxin and furan, PCBs, polybromodiphenyl ethers and polybromobiphenyls measured by by gas chromatography coupled to high-resolution mass spectrometry on double sector instruments (JEOL MS 700D and 800D) after electron impact ionization (70 eV), operating at 10000 resolutions (10% valley) and in the single ion monitoring (SIM) acquisition mode) in both adipose tissue and serum samples and 2) breast cancer status (with and without lymph node metastasis)	Sampling the day of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pro metastatic genes messenger ribonucleic acid (mARN) expression in the tumor based of metastatic lymph node status and persistant pollutants level.	Correlation between the mRNA levels of metastatic biomarkers measured by quantitative reverse transcriptase polymerase chain reaction amplification (PCR) in tumors (based of metastatic lymph node status) and the levels of persistant organic pollutants measured by gas chromatography coupled to high-resolution mass spectrometry. List of genes measured : Epithelial-to-mesenchymal (ECadherin, SNAIL, SLUG), matrix metalloproteases, metabolism, vascular endothelial grown factor, stem-cell properties, hormon receptor, inflammatory genes, xenobiotic receptor Aryl Hydrocarbon receptor (AhR).	2 years

Collaborators and Investigators

• Sponsor: European Georges Pompidou Hospital
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; ONIRIS
• Investigators: Principal Investigator: Anne-Sophie BATS, MD, PhD, European Hospital Georges Pompidou

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2013
• Primary Completion (Actual): December 27, 2013
• Study Completion (Actual): September 15, 2017

Study Registration Dates

• First Submitted: December 3, 2018
• First Submitted That Met QC Criteria: December 26, 2018
• First Posted (Actual): December 27, 2018

Study Record Updates

• Last Update Posted (Actual): December 27, 2018
• Last Update Submitted That Met QC Criteria: December 26, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Neoplastic Processes; Neoplasm Metastasis; Breast Neoplasms; Lymphatic Metastasis
• Other Study ID Numbers: 2013-A00663-42

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No