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Persistant Organics Pollutants in Breast Cancer. (METAPOP)

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ClinicalTrials.gov Identifier: NCT03788187
Recruitment Status : Completed
First Posted : December 27, 2018
Last Update Posted : December 27, 2018
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
ONIRIS
Information provided by (Responsible Party):
Koual Meriem, European Georges Pompidou Hospital

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)

Condition or disease Intervention/treatment Phase
Breast Cancer Persistant Organic Pollutants Lymph Node Metastases Other: Blood test sample Other: Peritumoral adipose tissue sample Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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).
Primary Purpose: Other
Official Title: Role of Persistant Organics Pollutants in the Metastatic Potential of Malignant Breast Tumor.
Actual Study Start Date : August 2013
Actual Primary Completion Date : December 27, 2013
Actual Study Completion Date : September 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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).




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788187


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

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Responsible Party: Koual Meriem, Associate professor, European Georges Pompidou Hospital
ClinicalTrials.gov Identifier: NCT03788187     History of Changes
Other Study ID Numbers: 2013-A00663-42
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases