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Persistent Organic Pollutants and Breast Cancers (POPCASE) (POPCASE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02890095
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Breast cancer surgery Procedure: plastic surgery Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective, Multicenter, Epidemiological Case-control Study, to Establish a Possible Correlation Between Persistent Chemical Contaminants (POPs) and Breast Cancer.
Study Start Date : January 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Arm A = Breast Cancer surgery
Arm A : women undergoing breast cancer surgery.
Procedure: Breast cancer surgery

First, 2 specific adipose tissue samples will be performed during the surgery :

  • 1 sample near the tumor, to measure the contaminants (dioxins, PCBs, organochlorine pesticides, polybrominated compounds)
  • 1 remote sample of the tumor bed, superficial, at least 5 cm from the tumor, to be used to determine the level of expression of hormone receptors and to establish the expression profiles, after cutting and inclusion in paraffin blocks for marking IHC.

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)


Arm B = Control (plastic surgery)
Arm B : women undergoing breast surgery for the purpose of plastic surgery
Procedure: 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:

  • measuring contaminants (dioxins, PCBs, organochlorine pesticides, polybrominated compounds)
  • to determine the level of expression of hormone receptors and to establish the expression profiles, after cutting and inclusion in paraffin blocks for marking IHC. These samples are all made during surgery, for usual care surgery these patients.

Before anaesthesia : specific blood samples (for the determination of circulating pollutants and for the analysis of gene polymorphism)





Primary Outcome Measures :
  1. 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:

    • Group A: women receiving breast cancer surgery,
    • Group B: women receiving breast surgery for the purpose of plastic surgery (control) This contamination profile is "exposure of interest" in this study. The quantification of this exposure is based on a targeted measure, by mass spectrometry, an expanded set of representative substances of the main families of lipophilic POPs (pesticides, PCBs, dioxins and polybrominated compounds) present to trace (femtomol).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women ≥ 18 and <75 years
  2. 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)
  3. Performance status (WHO) ≤ 1
  4. PNN ≥ 1500 / mm3 ; Platelets ≥ 100 000 /mm3 ; Hb ≥10 g / dL
  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:

  1. Patient with uncontrolled infection
  2. Patient pregnant or lactating
  3. Patient with a viral infection (HIV, Hepatitis B, Hepatitis C)
  4. Patient cannot be regularly monitored for psychological reasons, social, family or geographical.
  5. Patient Private of liberty or under a guardianship authority / curatorship.
  6. Arm A only: Patient to benefit from neoadjuvant therapy for breast cancer
  7. Arm A only Patient with metastatic breast cancer
  8. Arm A only Patient diagnosed cancer in situ (intra ductal)
  9. Arm A only Patient with BRCA1 or BRCA2 known
  10. Arm B only: previous breast plastic surgery, regardless of the type of intervention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890095


Contacts
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Contact: CAMPONE Mario +33 2 40 67 99 00 mario.campone@ico.unicancer.fr
Contact: PACTEAU Valérie +33 2 40 67 99 00 valerie.pacteau@ico.unicancer.fr

Locations
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France
ICO René Gauducheau Recruiting
Nantes - St herblain, France, 44805
Contact: CAMPONE Mario, MD, PH    +33 2 40 67 99 00    mario.campone@ico.unicancer.fr   
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
Investigators
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Principal Investigator: CAMPONE Mario Institut de Cancérologie de l'Ouest

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Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT02890095    
Other Study ID Numbers: ICO-N-2014-08
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases