Breast CancerMETAPOPNCT03788187
Persistant Organics Pollutants in Breast Cancer.
A study testing Blood test sample and Peritumoral adipose tissue sample in people with Breast Cancer and Persistant Organic Pollutants, run by European Georges Pompidou Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Persistant Organic Pollutants, Lymph Node Metastases
- What is being tested?
- Blood test sample and Peritumoral adipose tissue sample
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to 15 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
About this study
Official title: Role of Persistant Organics Pollutants in the Metastatic Potential of Malignant Breast Tumor.
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)
Read the 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).
- Being tested
- Blood test sample, Peritumoral adipose tissue sample
- Medical subject headings
- Breast Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood test sampleOther
Peritumoral adipose tissue sampleOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2018
- Study startAug 2013
- Primary completion27 Dec 2013
- Study completion15 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Georges Pompidou Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, ONIRIS
- Responsible party
- Principal investigator, Koual Meriem, European Georges Pompidou Hospital
- Investigators
- Anne-Sophie BATS, MD, PhD, Principal investigator, European Hospital Georges Pompidou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788187
- Sponsor's protocol ID
- 2013-A00663-42
- Acronym
- METAPOP
- Status last verified
- Dec 2018
- First submitted
- 3 Dec 2018
- Last updated
- 27 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Persistant Organics Pollutants in the Metastatic Potential of Malignant Breast Tumor.
- ClinicalTrials.gov ID
- NCT03788187
- Acronym / sponsor ID
- METAPOP / 2013-A00663-42
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- European Georges Pompidou HospitalUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, ONIRIS
- Study start
- Aug 2013 (actual)
- Primary completion
- 27 Dec 2013 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 27 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood test sample | Other | – |
| Peritumoral adipose tissue sample | Other | – |
Primary outcome
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)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Sophie BATS, MD, PhD principal investigator
European Hospital Georges Pompidou
Questions about this trial
What is this clinical trial studying?
A study testing Blood test sample and Peritumoral adipose tissue sample in people with Breast Cancer and Persistant Organic Pollutants, run by European Georges Pompidou Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2018.