Prospective, Multicenter, Epidemiological Case-control Study, to Establish a Possible Correlation Between Persistent Chemical Contaminants (POPs) and Breast Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 769
- 试验地点
- 6
- 主要终点
- correlation between the individual risk of breast cancer and persistent chemical contaminants
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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,
- •Patient who signed and dated informed consent form
- •Arm A only: unifocal lesion
- •Arm A only: Clinical stage M0
排除标准
- •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
研究组 & 干预措施
Arm A = Breast Cancer surgery
Arm A : women undergoing breast cancer surgery.
干预措施: Breast cancer surgery (Procedure)
Arm B = Control (plastic surgery)
Arm B : women undergoing breast surgery for the purpose of plastic surgery
干预措施: plastic surgery (Procedure)
结局指标
主要结局
correlation between the individual risk of breast cancer and persistent chemical contaminants
时间窗: 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).
次要结局
未报告次要终点