Informations générales (source: ClinicalTrials.gov)
Prospective, Multicenter, Epidemiological Case-control Study, to Establish a Possible Correlation Between Persistent Chemical Contaminants (POPs) and Breast Cancer.
Interventional
N/A
Institut Cancerologie de l'Ouest (Voir sur ClinicalTrials)
janvier 2016
juin 2034
12 septembre 2025
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).
Etablissements
Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
---|---|---|---|---|---|
CLCC INSTITUT GUSTAVE ROUSSY | Chafika MAZOUNI | 08/03/2024 12:50:01 | Contact (sur clinicalTrials) | ||
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
Clinique Breteche - 44046 - Nantes - France | Contact (sur clinicalTrials) | ||||
ICO René Gauducheau - 44805 - Saint-Herblain - France | Contact (sur clinicalTrials) |
Critères
Femme
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
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
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
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
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