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
About this trial
This is an interventional other trial for Breast Cancer
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
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
NCT ID
NCT03788187
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
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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