Persistant Organics Pollutants in Breast Cancer.

NCT ID: NCT03788187

Last Updated: 2018-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2017-09-15

Brief Summary

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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

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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).

Conditions

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Breast Cancer Persistant Organic Pollutants Lymph Node Metastases

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
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).

Interventions

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Blood test sample

Intervention Type OTHER

Peritumoral adipose tissue sample

Intervention Type OTHER

Eligibility Criteria

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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

* Dementia
* Guardianship
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

ONIRIS

INDUSTRY

Sponsor Role collaborator

European Georges Pompidou Hospital

OTHER

Sponsor Role lead

Responsible Party

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Koual Meriem

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne-Sophie BATS, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

European Hospital Georges Pompidou

Other Identifiers

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2013-A00663-42

Identifier Type: -

Identifier Source: org_study_id