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Trial record 47 of 193 for:    breast,cancer,prevention | Recruiting, Not yet recruiting, Available Studies

PRECAMA: Molecular Subtypes of Premenopausal Breast Cancer in Latin American Women (PRECAMA)

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ClinicalTrials.gov Identifier: NCT03144648
Recruitment Status : Recruiting
First Posted : May 9, 2017
Last Update Posted : May 9, 2017
Sponsor:
Collaborators:
University of Chile
Fundación Inciensa
Instituto Nacional de Salud Publica, Mexico
Universidad de Antioquia
Fred Hutchinson Cancer Research Center
Information provided by (Responsible Party):
International Agency for Research on Cancer

Brief 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.


Condition or disease Intervention/treatment
Breast Cancer Female Other: lifestyle

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Molecular Subtypes of Premenopausal Breast Cancer in Latin American Women (PRECAMA): a Multicenter Population-based Case-control Study
Actual Study Start Date : October 12, 2012
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Cases
Incident primary invasive breast cancer 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. For each subject, complete questionnaire data on socio-demographic factors, health and reproductive history, early risk factors, physical activity, diet, 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 is measured according to standardized protocols. Blood and urine samples are also collected for biomarker analyses. Highly standardized immunohistochemical and molecular analyses are performed to identify cancer subtypes
Other: lifestyle
Observational study

Controls
Women with no cancer recruited 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 and reproductive history, early risk factors, 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 is measured according to standardized protocols. Blood and urine samples are also collected for biomarker analyses.
Other: lifestyle
Observational study




Primary Outcome Measures :
  1. breast cancer [ Time Frame: at recruitment ]

Biospecimen Retention:   Samples With DNA
serum, plasma, red blood cells, buffy coats, urine, and for cases, DNA from tumor tissues


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Premenopausal Latin America women
Criteria

Inclusion Criteria:

  • woman between 20 and 45 years old
  • woman less than 3 years older or younger than the case
  • living in the area that the study is taking place during the past 3 years
  • woman menstruated at least once in the past 12 months
  • woman diagnosed with a primary breast cancer by histopathological examination (only for cases)

Exclusion Criteria:

  • woman receiving tumor treatment, such as radiotherapy, chemotherapy or anti-estrogens (for example, tamoxifen) (except treatment for non-melanoma skin cancers)
  • woman taking (or has previously taken) any of the following medications in the past 6 months: tamoxifen, Evista (raloxifene), Fareston (toremifene), Aromasin (exemestane), Femara (letrozole), Arimidez (anastrozole) or Megace (megestrol)
  • woman suffering from chronic kidney failure
  • woman having a pathology that will hinder adequate communication
  • woman who is pregnant or nursing
  • woman who has been previously diagnosed with a cancer(except for non-melanoma skin cancers)
  • any other reason to exclude

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03144648


Contacts
Contact: Sabina Rinaldi, PhD +33 472738485 ext 8328 rinaldis@iarc.fr

Locations
Chile
INC Recruiting
Santiago del Chile, Independencia, Chile
Contact: José Luis Soto, Dr    : +569 97990370    sotonoriega@gmail.com   
Contact: Paula Morales, Dr    +569 78800536    morales.paulita@gmail.com   
Principal Investigator: Maria Luisa Garmendia, PhD         
Hso-Crsco Recruiting
Santiago, Peñalolén, Chile
Contact: Verónica Toledo, Dr    +569 90701988    vetoledo@gmail.com   
Contact: Herna Travisany    +569 66292855    htravisany@gmail.com   
Principal Investigator: Maria Luisa Garmendia, PhD         
FALP Recruiting
Santiago, Providencia, Chile
Contact: Eva Bustamante, PhD    +569 74995745    bustamantee@falp.org   
Contact: Johanna Wettlin    +569 99941675    johanna.wettlin@falp.org   
Principal Investigator: Maria Luisa Garmendia, PhD         
Colombia
Grupo Infección y Cáncer. Universidad de Antioquia Recruiting
Medellín, Antioquia, Colombia, 050010
Contact: Gloria Sanchez, MSc, PhD    +57 3014201831    gloria.sanchez@udea.edu.co   
Contact: Maria Agudelo, MD    +57 3012974825    ceci886@hotmail.com   
Costa Rica
Agencia Costarricense de Investigaciones Biomédicas (ACIB) Recruiting
Rohrmoser, San Jose, Costa Rica
Contact: Carolina Porras       cporras@acibcr.com   
Principal Investigator: Carolina Porras, PhD         
Mexico
Instituto Nacional de Salud Pública (INSP) Recruiting
Cuernavaca, Morelos, Mexico, 69100
Contact: Gabriela Torres-Mejía, PhD    (777) 311 1960    gtorres@insp.mx   
Contact: Angélica Ángeles-Lllerenas, DrPh    (777) 311 1960    aangelica@insp.mx   
Principal Investigator: Gabriela Torres-Mejía         
Sponsors and Collaborators
International Agency for Research on Cancer
University of Chile
Fundación Inciensa
Instituto Nacional de Salud Publica, Mexico
Universidad de Antioquia
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Sabina Rinaldi, PhD International Agency for Research on Cancer, Lyon, France
Principal Investigator: Maria Luisa Garmendia, PhD Instituto de Nutrición y Tecnología de los Alimentos, Universidad de Chile, Santiago, Chile
Principal Investigator: Carolina Porras, PhD Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, Costa Rica
Principal Investigator: Gabriela Torres-Mejía, PhD nstituto Nacional de Salud Pública, Cuernavaca, Mexico
Principal Investigator: Gloria I Sánchez, PhD Grupo Infección y Cáncer, Facultad de Medicina, Universidad de Antioquía, Medellín, Colombia
Principal Investigator: Peggy Porter, PhD Fred Hutchinson Cancer Research Center, Seattle, USA

Additional Information:
Responsible Party: International Agency for Research on Cancer
ClinicalTrials.gov Identifier: NCT03144648     History of Changes
Other Study ID Numbers: PRECAMA
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases