Persistant Organics Pollutants in Breast Cancer.

Breast Cancer Clinical Trial

— METAPOP  

Official title:

Role of Persistant Organics Pollutants in the Metastatic Potential of Malignant Breast Tumor.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03788187
• Other study ID #: 2013-A00663-42
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: September 15, 2017

Study information

• Verified date: December 2018
• Source: European Georges Pompidou Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 15, 2017
• Est. primary completion date: December 27, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymph Node Metastases
• Persistant Organic Pollutants

Intervention

Other:
• Blood test sample

• Peritumoral adipose tissue sample

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
European Georges Pompidou Hospital	Institut National de la Santé Et de la Recherche Médicale, France, ONIRIS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Sampling the day of surgery
Secondary	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).	2 years