Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT03144648 |
Other study ID # |
PRECAMA |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
October 12, 2012 |
Est. completion date |
December 30, 2025 |
Study information
Verified date |
October 2023 |
Source |
International Agency for Research on Cancer |
Contact |
Sabina Rinaldi, PhD |
Phone |
+33 472738485 |
Email |
rinaldis[@]iarc.who.int |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Breast cancer has become a major public health problem in Latin America, as it is the most
common form of cancer among women. Women are more likely to develop breast cancer at younger
age, and to be diagnosed at an advanced stage compared to western women. Over the past twenty
years, the mortality from breast cancer in Latin America has also been increasing very
rapidly, and is currently the leading cause of cancer mortality. Little is known on specific
risk factors for premenopausal breast cancer in general, and in Latin America in particular.
There is a lack of specific knowledge on tumor molecular and pathological characteristics of
breast cancer in Latin America premenopausal women, and this has major consequences on cancer
treatment and survival.
To improve our understanding on determinants of breast cancer incidence and mortality in
young Latin America women and support preventive actions, we implemented an international,
population-based multi-center study in Latin America: the PRECAMA study (Molecular Subtypes
of Premenopausal Breast Cancer in Latin American Women (PRECAMA): a multicenter
population-based case-control study).
PRECAMA is coordinated by the International Agency for Research on Cancer (IARC), and is
conducted within 4 Latin American countries: Mexico, Costa Rica, Colombia and Chile. Major
aims of the project are the following:
1. To develop a multi-centric population-based case-control study on breast cancer in
premenopausal women in several countries in Latin America with structured collection of
individual, clinical, pathological information and biological specimens, according to
strictly controlled protocols
2. To characterize, in these populations, the subtypes of premenopausal breast cancer on
the basis of their molecular and pathological phenotypes
3. To improve the identification of specific endogenous/exogenous factors, and disentangle
the interplay of these different factors with regard to breast tumor subtypes.
4. Provide advanced training, induce a structuring effect on the breast cancer research
community in Latin America and influence the public health agenda regarding the
management of breast cancer.
The results of our study will be of utmost importance to understand the etiology of breast
cancer in Latin America countries, and would provide important information on the role of
modifiable exposures for breast cancer prevention.
Description:
Breast cancer (BC) has become a major public health problem in Latin America (LA), as it is
the most common form of cancer among women. In Women are more likely to develop BC at younger
age, and to be diagnosed at an advanced stage compared to western women. Over the past twenty
years, the mortality from BC in LA has also been increasing very rapidly, and is currently
the leading cause of cancer mortality among LA women. The large number of incident BC cases
among premenopausal women, which is only partly explained by the population age-structure, is
therefore of major concern. Little is known on specific risk factors for premenopausal BC in
general, and in LA in particular, and risk factors related to diet, obesity and low physical
activity play a role on incidence and mortality. Estrogen receptor (ER) and/or Progesterone
receptor (PR) expression in breast tumors may differ according to risk factors and to
molecular pathological characteristics. There is a lack of specific knowledge on tumor
molecular and pathological characteristics of BC in premenopausal women, particularly in
lower resource countries where the hormone-dependence status is poorly documented. This has
major consequences on cancer treatment and survival.
To improve our understanding of determinants of BC incidence and mortality in young Latin
America women and support preventive actions, we implemented an international,
population-based multi-center case-control study in LA: the PRECAMA study (Molecular Subtypes
of Premenopausal Breast Cancer in Latin American Women (PRECAMA): a multicenter
population-based case-control study).
PRECAMA is coordinated by the International Agency for Research on Cancer (IARC), and is
conducted within 4 Latin American countries: Mexico, Costa Rica, Colombia and Chile. Major
aims of the project are the following:
1. To develop a multi-centric population-based case-control study on BC in premenopausal
women in several countries in LA with structured collection of individual, clinical,
pathological information and biological specimens, according to strictly controlled
protocols
2. To characterize, in these populations, the subtypes of premenopausal BC on the basis of
their molecular and pathological phenotypes
3. To improve the identification of specific endogenous/exogenous factors, and disentangle
the interplay of these different factors with regard to breast tumor subtypes.
4. Provide advanced training, induce a structuring effect on the BC research community in
LA and influence the public health agenda regarding the management of BC.
Standardized methods and questionnaires have been developed and implemented as well as
standard operating procedures for laboratory activities. Incident primary invasive cases aged
20-45 years are recruited from major cancer hospitals in four large Latin American cities
(Mexico City, San Jose, Medellin, and Santiago) prior to any treatments. Controls for the
study are selected from the population residing in the same cities for at least 3 years and
matched to cases on age (+/- 5 years) and health care institution. For each subject, complete
questionnaire data on socio-demographic factors, health history, reproductive history, use of
hormones, early risk factors, body silhouette at different ages, physical activity, diet,
occupation, environmental risk factors, ethnicity, and family history of cancer are
collected. Validated and standardized food frequency questionnaires are administered to
gather information on diet. Anthropometry (body weight, standing and sitting height, waist
and hip circumferences) are measured according to standardized protocols. Blood and urine
samples are also collected for biomarker analyses. For all cases, highly standardized
immunohistochemical and molecular analyses are performed to identify BC subtypes.
The results of our study will be of utmost importance to understand the etiology of breast
cancer in Latin America countries in epidemiological transition, and would provide important
information on the role of modifiable exposures on the disease which may provide important
support for breast cancer prevention.