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Persistant Organics Pollutants in Breast Cancer. (METAPOP)

Primary Purpose

Breast Cancer, Persistant Organic Pollutants, Lymph Node Metastases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blood test sample
Peritumoral adipose tissue sample
Sponsored by
European Georges Pompidou Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    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).

    Full Information

    First Posted
    December 3, 2018
    Last Updated
    December 26, 2018
    Sponsor
    European Georges Pompidou Hospital
    Collaborators
    Institut National de la Santé Et de la Recherche Médicale, France, ONIRIS
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03788187
    Brief Title
    Persistant Organics Pollutants in Breast Cancer.
    Acronym
    METAPOP
    Official Title
    Role of Persistant Organics Pollutants in the Metastatic Potential of Malignant Breast Tumor.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2013 (Actual)
    Primary Completion Date
    December 27, 2013 (Actual)
    Study Completion Date
    September 15, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    European Georges Pompidou Hospital
    Collaborators
    Institut National de la Santé Et de la Recherche Médicale, France, ONIRIS

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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)
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Persistant Organic Pollutants, Lymph Node Metastases

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Masking Description
    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).
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    Blood test sample
    Intervention Type
    Other
    Intervention Name(s)
    Peritumoral adipose tissue sample
    Primary Outcome Measure Information:
    Title
    Metastatic lymph node status based of persistant organic pollutants level measured by by gas chromatography coupled to high-resolution mass spectrometry.
    Description
    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)
    Time Frame
    Sampling the day of surgery
    Secondary Outcome Measure Information:
    Title
    Pro metastatic genes messenger ribonucleic acid (mARN) expression in the tumor based of metastatic lymph node status and persistant pollutants level.
    Description
    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).
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anne-Sophie BATS, MD, PhD
    Organizational Affiliation
    European Hospital Georges Pompidou
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Persistant Organics Pollutants in Breast Cancer.

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