- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02890095
Persistent Organic Pollutants and Breast Cancers (POPCASE) (POPCASE)
Prospective, Multicenter, Epidemiological Case-control Study, to Establish a Possible Correlation Between Persistent Chemical Contaminants (POPs) and Breast Cancer.
Exposure to certain classes of chemical contaminants, including certain persistent organic pollutants (POPs) with a character of endocrine disruptors, could be one of the factors that lead to increase incidence of breast cancer in the Western world .
However, the causal role of POPs in the onset of breast cancer remains nowadays unproven. Preliminary epidemiological studies on the impact of these environmental factors in breast cancer etiology have ignored the critical periods of exposure. Similarly, they have considered a limited number of pollutants (not including possible joint or synergistic effects between individual compounds) and did not distinguish the different breast cancer subtypes may have different etiologies or even of genetic susceptibility factors (POP polymorphism of detoxification enzymes).
Thus, POPCASE study examines the association between the presence of breast cancer and the levels and exposure profiles to a group of POPs measured in adipose tissue (AT) and blood, in particular using spectrometric methods developed by the team LABERCA (Nantes, France). These internal levels of POPs (organochlorine pesticides, dioxins, PCBs, brominated flame retardants) will be measured both quantitatively (tissue concentrations) and qualitative (relative proportions of different pollutants sought).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Exposure to certain classes of chemical contaminants, including certain persistent organic pollutants (POPs) with a character of endocrine disruptors, could be one of the factors that lead to increase incidence of breast cancer in the Western world .
However, the causal role of POPs in the onset of breast cancer remains nowadays unproven. Preliminary epidemiological studies on the impact of these environmental factors in breast cancer etiology have ignored the critical periods of exposure. Similarly, they have considered a limited number of pollutants (not including possible joint or synergistic effects between individual compounds) and did not distinguish the different breast cancer subtypes may have different etiologies or even of genetic susceptibility factors (POP polymorphism of detoxification enzymes).
Finally, this demonstration has not been done for 2 reasons:
- Multidisciplinary Issues,
- Need innovative tools for statistical analysis and interpretation of these more integrated environmental data.
Thus, POPCASE study examines the association between the presence of breast cancer and the levels and exposure profiles to a group of POPs measured in adipose tissue (AT) and blood, in particular using spectrometric methods developed by the team LABERCA (Nantes, France). These internal levels of POPs (organochlorine pesticides, dioxins, PCBs, brominated flame retardants) will be measured both quantitatively (tissue concentrations) and qualitative (relative proportions of different pollutants sought).
It is therefore to improve the level of knowledge between environmental chemical exposure and increased incidence of breast cancer (in its environmental, genetic and molecular components) within the general population, in response to a public health issue, the question of the actual impact on the health of major classes of chemical pollutants present in our environment and our staying power behind debates and being associated with high stakes, both scientists but economic and societal.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mario CAMPONE, MD, PhD
- Phone Number: +33240679900
- Email: mario.campone@ico.unicancer.fr
Study Contact Backup
- Name: Nadia ALLAM, PHD
- Phone Number: +33240679826
- Email: nadia.allam@ico.unicancer.fr
Study Locations
-
-
-
Nantes, France, 44046
- Recruiting
- Clinique Breteche
-
Contact:
- Anne Laure Bouffaut, MD
- Phone Number: +33890710711
- Email: bouffautal@yahoo.fr
-
Saint-Herblain, France, 44805
- Recruiting
- ICO René Gauducheau
-
Contact:
- CAMPONE Mario, MD, PH
- Phone Number: +33 2 40 67 99 00
- Email: mario.campone@ico.unicancer.fr
-
Villejuif, France, 94800
- Recruiting
- Gustave Roussy
-
Contact:
- Angelica CONVERSANO, MD
- Phone Number: +33142114211
- Email: angelica.conversano@gustaveroussy.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women ≥ 18 and <75 years
According to the arm:
- Arm A: histologically confirmed diagnosis of invasive breast cancer (only), unilateral or bilateral, outside off recurrence and relapse. Patients who have been supported for a contralateral breast cancer can be included if a period of at least 2-years between the last systemic treatment of inclusion in the study.
- Arm B: Any woman operated on for breast plastic surgery (breast lift and breast reduction cure only)
- Performance status (WHO) ≤ 1
5. Patient affiliated to a social security scheme, 6. Patient who signed and dated informed consent form 7. Arm A only: unifocal lesion 8. Arm A only: Clinical stage M0
Exclusion Criteria:
- Patient with uncontrolled infection
- Patient pregnant or lactating
- Patient with a viral infection (HIV, Hepatitis B, Hepatitis C)
- Patient cannot be regularly monitored for psychological reasons, social, family or geographical.
- Patient Private of liberty or under a guardianship authority / curatorship.
- Arm A only: Patient to benefit from neoadjuvant therapy for breast cancer
- Arm A only Patient with metastatic breast cancer
- Arm A only Patient diagnosed cancer in situ (intra ductal)
- Arm A only Patient with BRCA1 or BRCA2 known
- Arm B only: previous breast plastic surgery, regardless of the type of intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A = Breast Cancer surgery
Arm A : women undergoing breast cancer surgery.
|
First, 2 specific adipose tissue samples will be performed during the surgery :
These withdrawals are made during surgery, during surgery, as part of the intervention and the remodeling of the mammary gland (standard care for patients). This is unused balance for diagnostic. Before anaesthesia : specific blood samples (for the determination of circulating pollutants and for the analysis of gene polymorphism) |
Other: Arm B = Control (plastic surgery)
Arm B : women undergoing breast surgery for the purpose of plastic surgery
|
The excision piece will follow the classical pathological circuit. A specific charge of subcutaneous adipose tissue will be performed as part of research on the surgical specimen. This sample will be used:
Before anaesthesia : specific blood samples (for the determination of circulating pollutants and for the analysis of gene polymorphism) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
correlation between the individual risk of breast cancer and persistent chemical contaminants
Time Frame: 10 years after surgery
|
The main objective is to establish a correlation between the individual risk of breast cancer and persistent chemical contaminants (POPs) respectively measured in adipose tissue (i.e. storage compartment) and blood (i.e. circulating compartment). => Comparison of the assay in the body of a set of chemical pollutants in the environment between the following two groups:
|
10 years after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mario CAMPONE, MD, PhD, Institut de Cancérologie de l'Ouest
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICO-N-2014-08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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