Breast Cancer Clinical Trial
Official title:
Pregnant Exposure to Persistent Organic Pollutants With Endocrine Disrupting Activity and Development of Breast Cancer in the Next 15 Years: Longitudinal Prospective Cohort Nested Case-control Study
Breast cancer, the first female cancer, affects one in eight women in her lifetime. The
increase and uneven distribution of its prevalence throughout the world cannot be fully
explained either by the increase in life expectancy, or by genetic factors present in less
than 10% of cases, or by early detection, or by the use of hormone therapy for menopause at
certain periods of time.
Numerous experimental and epidemiological arguments, as well as the increased risk of breast
cancer in women after 50 years of age who were exposed in utero to Distilbene prescribed for
their mothers in the 1950s to 75's, suggest the involvement of environmental factors involved
in early development (nutrition, alcohol, tobacco, chemical pollutants) that may act as
endocrine disruptors, estrogenomimetic or intervening on other nuclear receptors such as the
However, the formal demonstration of the deleterious physiopathological role of such exposure
comes up against methodological difficulties in epidemiological terms: first of all, the fact
that correlation is sought at the time of the discovery of breast cancer when there are
critical windows of exposure (fetal, perinatal, peripubertal and pregnant) and that
persistent organic products or POPs, most often lipids, are present.
The objective of this project is to correlate the per-gravidic exposure to POPs (dioxins,
dioxinlike, polychlorinated bisphenyls, organochlorine pesticides and flame-retardant
polybrominated derivatives) and the development, within 15 years of delivery, of breast
cancer, taking into account the confounding factors of classical breast cancer risk (age,
reproductive events, etc.).
This project benefits on the one hand from a cord blood bank set up between 2002 and 2005
(6,242 samples) carried out at the Nice University Hospital and the Grasse University
Hospital, during a PHRC and on the other hand from the cancer observatory / CRISAP of the
PACA Corsica region, exhaustive to more than 92% since 2005, registers which will be
cross-referenced and whose cancer cases (N) will be compared to controls. The assays will be
carried out after purification, using high-resolution mass spectrometry gas chromatography
coupling, the quantification being carried out according to the principle of isotopic
dilution. They will be carried out by LABERCA in Nantes, the national reference laboratory of
the French Health Agencies ANSES and INVS and also involved in various European projects.
Concentrations related to blood lipids will be expressed in quartile and analyzed separately
or combined with a cumulative score taking into account confounding risk factors for breast
cancer and the geolocation of the initial and final residence in relation to the incinerator
of the City of Nice (Department of Public Health CHU of Nice).
Breast cancer, the first female cancer, affects one in eight women in her lifetime. The
increase and uneven distribution of its prevalence throughout the world cannot be fully
explained either by the increase in life expectancy, or by genetic factors present in less
than 10% of cases, or by early detection, or by the use of hormone therapy for menopause at
certain periods of time.
Numerous experimental and epidemiological arguments, as well as the increased risk of breast
cancer in women after 50 years of age who were exposed in utero to Distilbene prescribed for
their mothers in the 1950s to 75's, suggest the involvement of environmental factors involved
in early development (nutrition, alcohol, tobacco, chemical pollutants) that may act as
endocrine disruptors, estrogenomimetic or intervening on other nuclear receptors such as the
However, the formal demonstration of the deleterious physiopathological role of such exposure
comes up against methodological difficulties in epidemiological terms: first of all, the fact
that correlation is sought at the time of the discovery of breast cancer when there are
critical windows of exposure (fetal, perinatal, peripubertal and pregnant) and that
persistent organic products or POPs, most often lipids, are present.
The objective of this project is to correlate the per-gravidic exposure to POPs (dioxins,
dioxinlike, polychlorinated bisphenyls, organochlorine pesticides and flame-retardant
polybrominated derivatives) and the development, within 15 years of delivery, of breast
cancer, taking into account the confounding factors of classical breast cancer risk (age,
reproductive events, etc.).
This project benefits on the one hand from a cord blood bank set up between 2002 and 2005
(6,242 samples) carried out at the Nice University Hospital and the Grasse University
Hospital, during a PHRC and on the other hand from the cancer observatory / CRISAP of the
PACA Corsica region, exhaustive to more than 92% since 2005, registers which will be
cross-referenced and whose cancer cases (N) will be compared to controls. The assays will be
carried out after purification, using high-resolution mass spectrometry gas chromatography
coupling, the quantification being carried out according to the principle of isotopic
dilution. They will be carried out by LABERCA in Nantes, the national reference laboratory of
the French Health Agencies ANSES and INVS and also involved in various European projects.
Concentrations related to blood lipids will be expressed in quartile and analyzed separately
or combined with a cumulative score taking into account confounding risk factors for breast
cancer and the geolocation of the initial and final residence in relation to the incinerator
of the City of Nice (Department of Public Health CHU of Nice).
The implementation of such a protocol requires a preliminary feasibility phase, which is the
subject of this AOI request and which will depend on:
1. Sending a letter to the 6242 mothers whose sera (derived from cord blood) are stored in
the bank set up between 2002 and 2005 in order to
1. Verify that they still live in the PACA region
2. confirm their willingness to participate in this study on the exposure/emergence
relationship of breast cancer by serum assay.
(c) indicate whether they agree to be part of the follow-up cohort
2. Determination, by crossing the two registers (cord blood bank) and cancer register /
CRISAP, of women who gave birth at the Nice University Hospital or at the Grasse
University Hospital of a boy between 2002 and 2005 and who developed breast cancer in
the next 13 years (considered N cases); who have not developed breast cancer and will be
matched for age and date of delivery (controls 2N).
3. Determination of their gynaecological characteristics, breast cancer risk factors and
cancer characteristics.
The project will then continue beyond the AOI, through the determination of dioxins,
dioxins-like, PCBs and brominated derivatives in the context of specific funding, and the
analysis of results.
These privileged conditions should make it possible, by resolving some of the methodological
difficulties inherent in the environmental epidemiology of cancers, to provide information on
the possible role of exposure to persistent organic products during critical periods, such as
pregnancy in the occurrence of breast cancer, and to justify preventive measures and the
development of new predictive risk factors.
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