Persistant Organics Pollutants in Breast Cancer.

NCT03788187 | Completed DMC

• 1 other identifier: 2013-A00663-42
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Breast Cancer; Persistant Organic Pollutants; Lymph Node Metastases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pro metastatic genes messenger ribonucleic acid (mARN) expression in the tumor based of metastatic lymph node status and persistant pollutants level.

  2 years

Interventions

Blood test sample OTHER

Peritumoral adipose tissue sample OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Dementia
• Guardianship

Sponsors & Collaborators

• European Georges Pompidou Hospital: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• ONIRIS: collaborator

MeSH Terms

Conditions

Breast Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne-Sophie BATS, MD, PhD

  European Hospital Georges Pompidou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 27, 2018
• Study Start: August 1, 2013
• Primary Completion: December 27, 2013
• Study Completion: September 15, 2017
• Last Updated: December 27, 2018

Record last verified: 2018-12