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
Verified date | November 2017 |
Source | Centre Hospitalier Universitaire de Nice |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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).
Status | Completed |
Enrollment | 155 |
Est. completion date | May 1, 2017 |
Est. primary completion date | May 1, 2017 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: woman who gave birth between 2002 and 2005 to a boy whose cord blood was stored in a 2002/2005 PHRC. |
Country | Name | City | State |
---|---|---|---|
France | Nice Hospital | Nice |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nice |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the Number of blood samples usable by return of patient non-opposition | To make it possible from a regulatory and ethical point of view to use the exceptional bank of 6242 cord blood samples collected between 2002 and 2005 in the Nice (CHU) and Grasse maternity hospitals (CHR) and stored in the biochemistry laboratory (CHU Nice) in order to seek an association between the per-gravidic exposure to the main persistent organic pollutants of dioxins or dioxins-like type and the early onset in pregnant women. | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Recruiting |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A |