From May to October 2012, a case-control study was conducted
at the surgery department of the Salah Azaiz Hospital of Tunis and
at the Cancer Center of Ariana Hospital (Tunisia). Case subjects
were women suffering from breast cancer and hospitalized for a
mastectomy, tumourectomy (Salah Azaiz Hospital) or chemotherapy
treatment (Cancer Center of Ariana). Patients diagnosed with either, invasive ductal carcinoma (IDC) or ductal carcinoma in situ
(DCIS), were included in this study as it aims to investigate if there
is a correlation between zearalenone, its metabolites and breast
cancer, independently of the type or grade of cancer. Inclusion criteria
for cases included being able to give informed consent and to
complete a questionnaire. Exclusion criteria included a previous
history of breast cancer or any other type of cancer and the presence
of distant metastasis at diagnosis. Of the 96 eligible women,
69 (72%) agreed to participate and provided signed consent and a
sample of the first urine. Urine samples were collected before surgery
or chemotherapy. Control subjects were selected at random
from a healthy population of women including hospital visitors,
hospital staff and blood donors, aged over 18 years. Inclusion criteria
for controls included being able to give informed consent and to
complete a questionnaire. Exclusion criteria included the presence
of any hormone-related cancer or disease. Of the 77 eligible
women, 56 (73%) agreed to participate in the study, of which 15
(20%) did not provide a large enough volume of urine to carry
out the analysis.
In total, 69 cases (67 with IDC and 2 with DCIS) and 41 controls
were included in the study. All subjects participated in a face-toface
interview. The interview covered socio-demographic factors,
a full medical and reproductive history and lifestyle habits.
Table 1 shows the description of the study population.
The study was approved by the Ethics Committee of the Salah
Azaiz Hospital. All subject data were coded for confidentiality.