Breast CancerPOPCASENCT02890095
Persistent Organic Pollutants and Breast Cancers (POPCASE)
A study testing Breast cancer surgery and plastic surgery in people with Breast Cancer, run by Institut Cancerologie de l'Ouest at 3 sites in France.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breast cancer surgery and plastic surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 769 participants
- Where
- 3 sitesFrance
- Study dates
- Jan 2016to Jun 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Clinique Breteche
Nantes, 44046
ICO René Gauducheau
Saint-Herblain, 44805
Gustave Roussy
Villejuif, 94800
About this study
Official title: 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).
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Breast cancer surgery, plastic surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast cancer surgeryProcedure or 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)
plastic surgeryProcedure or 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)
| Study group | Role | What they receive |
|---|---|---|
| Arm A = Breast Cancer surgery | Experimental | Arm A : women undergoing breast cancer surgery. Receives: Procedure: Breast cancer surgery |
| Arm B = Control (plastic surgery) | Other | Arm B : women undergoing breast surgery for the purpose of plastic surgery Receives: Procedure: plastic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between the individual risk of breast cancer and persistent chemical contaminants
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).
Measured: 10 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startJan 2016
- Primary completion5 Jun 2024
- Study completionJun 2034 (estimated)
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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 769 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mario CAMPONE, MD, PhD, Principal investigator, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890095
- Sponsor's protocol ID
- ICO-N-2014-08
- Acronym
- POPCASE
- Status last verified
- Nov 2024
- First submitted
- 31 Aug 2016
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Epidemiological Case-control Study, to Establish a Possible Correlation Between Persistent Chemical Contaminants (POPs) and Breast Cancer.
- ClinicalTrials.gov ID
- NCT02890095
- Acronym / sponsor ID
- POPCASE / ICO-N-2014-08
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 769 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- Jun 2034 (estimated)
- First posted
- 7 Sep 2016 (estimated)
- 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.
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).
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A = Breast Cancer surgery | Experimental | Procedure: Breast cancer surgeryArm A : women undergoing breast cancer surgery. |
| Arm B = Control (plastic surgery) | Other | Procedure: plastic surgeryArm B : women undergoing breast surgery for the purpose of plastic surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women ≥ 18 and <75 years
- According to the arm:
- 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
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| Breast cancer surgeryFirst, 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) | Procedure or surgery | Arm A = Breast Cancer surgery |
| plastic surgeryThe 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) | Procedure or surgery | Arm B = Control (plastic surgery) |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Mario CAMPONE, MD, PhD principal investigator
Institut de Cancérologie de l'Ouest
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast cancer surgery and plastic surgery in people with Breast Cancer, run by Institut Cancerologie de l'Ouest at 3 sites in France.
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 6 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
correlation between the individual risk of breast cancer and persistent chemical contaminants (time frame: 10 years after 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 7 Nov 2024.