Persistant Organics Pollutants in Breast Cancer. (METAPOP)

December 26, 2018 updated by: Koual Meriem, European Georges Pompidou Hospital

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

Intervention / Treatment

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)

Phase

Not Applicable

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

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

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

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. Time Frame: Sampling the day of surgery	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. Time Frame: 2 years	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

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

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

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)

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)