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Prospective Evaluation of Breast Cancer at Brazilian Institutions - Project AMAZONA III

This study is currently recruiting participants.
Verified February 2017 by Latin American Cooperative Oncology Group
Sponsor:
ClinicalTrials.gov Identifier:
NCT02663973
First Posted: January 26, 2016
Last Update Posted: February 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Ministry of Health, Brazil
Avon Institute
Information provided by (Responsible Party):
Latin American Cooperative Oncology Group
  Purpose
The principal goal of this study is to describe the epidemiology of breast cancer in the Brazilian population

Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Evaluation of Breast Cancer at Brazilian Institutions - Project AMAZONA III

Resource links provided by NLM:


Further study details as provided by Latin American Cooperative Oncology Group:

Primary Outcome Measures:
  • Description of the epidemiology of breast cancer in the Brazilian population [ Time Frame: Annually, during 5 years ]

Secondary Outcome Measures:
  • Description of the socioeconomical characteristics of the Brazilian population with breast cancer [ Time Frame: Annually, during 5 years ]
  • Characterization of the immunophenotypic markers of the tumor [ Time Frame: Annually, during 5 years ]
    estrogen receptor, progesterone receptor, HER2, Ki67

  • Classification of breast cancer staging [ Time Frame: Annually, during 5 years ]
  • Description of screening tests of breast cancer patients in Brazil [ Time Frame: Annually, during 5 years ]
  • Main symptoms presented by patients with breast cancer in Brazil [ Time Frame: Annually, during 5 years ]
  • Initial treatment for breast cancer of Brazilian patients [ Time Frame: Annually, during 5 years ]
  • Type of palliative treatment for metastasis or recurrent breast cancer in Brazilian patients [ Time Frame: Annually, during 5 years ]
  • Clinical outcome of Brazilian breast cancer patients [ Time Frame: Annually, during 5 years ]
  • Types of clinical complications displayed by breast cancer Brazilian patients [ Time Frame: Annually, during 5 years ]
  • Characterization of exterior factors that may impact clinical outcome of breast cancer Brazilian patients [ Time Frame: Annually, during 5 years ]

Estimated Enrollment: 3000
Study Start Date: January 2016
Estimated Study Completion Date: April 2021
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Detailed Description:

The principal goal of this study is to describe the epidemiology of breast cancer in the Brazilian population. Other specific goals are:

  • To evaluate the demographic and socio-demographic profile, comorbidities and reproductive risks, anthropometric profile and family history.
  • Characterize the breast tumors immunophenotype through anatomopathological data, such as: tumor grade, estrogen receptor, progesterone receptor, HER2, Ki67.
  • Describe the screening tests, main symptoms and cancer stage in the moment of the diagnosis.
  • Describe the initial cancer treatment and locally advanced such as surgery, radiotherapy, chemotherapy and endocrine therapy.
  • Describe palliative treatment for recurrent or metastatic breast cancer: chemotherapy, radiotherapy, biphosphonate, and others.
  • Evaluate the clinical outcomes such as: local or diffuse relapse, period of time until progression to metastatic cancer, global lifespan and specific breast cancer lifespan.
  • Evaluate clinical complications of the metastatic disease, such as: brain metastasis, spinal cord compression, skeletal related events.
  • Analyze the demographical and socio-economical characteristics, clinical-pathological characteristics of the tumor, treatment, clinical outcomes, type of institution (private/public), and other factors that may impact clinical outcome.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Woman ≥ 18 years old with recent diagnosis of breast cancer
Criteria

Inclusion Criteria:

  • Woman ≥ 18 years old
  • Invasive breast cancer stage I to IV proven by histology or cytology
  • Patients with new pathological diagnosis of invasive primary BC after the site activation date
  • Pathological diagnosis of invasive breast cancer during recruitment (6 months before center activation or until 3000 patients included)
  • New primary cancer on the same breast or contralateral breast.
  • Patient's medical chart is available and adequate for data collection
  • Patient properly signed the informed consent form
  Contacts and Locations
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): NCT02663973


Contacts
Contact: Laura Voelcker laura.voelcker@lacog.org.br
Contact: Raíra Maschmann raira.maschmann@lacog.org.br

Locations
Brazil
Clínica AMO Recruiting
Salvador, Bahia, Brazil
Contact: Vanessa Dybal, MD         
Núcleo de Oncologia da Bahia Recruiting
Salvador, Bahia, Brazil
Contact: Clarissa Mathias, MD         
Centro Regional Integrado de Oncologia (CRIO) Recruiting
Fortaleza, Ceará, Brazil
Contact: Eduardo Henrique Cronenberger, MD         
Centro de Pesquisa do Setor de Ginecologia e Mama do Hospital Araújo Jorge Recruiting
Goiânia, Goiás, Brazil
Contact: Geraldo Queiroz, MD         
Unidade de Pesquisa Clínica/Hospital de Clínicas da UFG Recruiting
Goiânia, Goiás, Brazil
Contact: Ruffo Freitas Júnior, MD         
Unidade de Pesquisa Clínica do Hospital do Câncer de Londrina Recruiting
Londrina, Paraná, Brazil
Contact: José Couto Filho, MD         
Hospital Jardim Amália Not yet recruiting
Volta Redonda, Rio de Janeiro, Brazil
Contact: Viviane Lima         
Principal Investigator: Heloísa Resende, MD         
Centro de Pesquisa Clínica da Liga Norte Riograndense Contra o Câncer Recruiting
Natal, Rio Grande do Norte, Brazil
Contact: Karla Emerenciano, MD         
Centro de Pesquisas da Serra Gaúcha Recruiting
Caxias do Sul, Rio Grande do Sul, Brazil
Contact: Monique Binotto         
Principal Investigator: Tomás Reinert, MD         
Instituto de Pesquisa Clínicas para Estudos Multicêntricos da UCS Recruiting
Caxias do Sul, Rio Grande do Sul, Brazil
Contact: André Reiriz, MD         
Hospital da Cidade de Passo Fundo - Clínica CITO Recruiting
Passo Fundo, Rio Grande do Sul, Brazil
Contact: Nicolas Lazaretti, MD         
Hospital São Vicente de Paulo Recruiting
Passo Fundo, Rio Grande do Sul, Brazil
Contact: Giovana Vacaro, MD         
Grupo de Estudos em Pesquisa de Pelotas Recruiting
Pelotas, Rio Grande do Sul, Brazil
Contact: Cristiane Petrarca, MD         
CPO - Pucrs Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Contact: Carlos Barrios, MD         
Hospital Moinhos de Vento Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Contact: Daniela Rosa, MD         
Novos Tratamentos em Câncer - Hospital Santa Casa de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Contact: Manuela Zereu, MD         
CEPON Recruiting
Florianópolis, Santa Catarina, Brazil
Contact: Yeni Nerón, MD         
Clínica de Neoplasias Litoral - Centro de Novos Tratamentos Itajaí Recruiting
Itajaí, Santa Catarina, Brazil
Contact: Giuliano Borges, MD         
Instituto Oncológico de Ribeirão Preto - InORP Recruiting
Ribeirão Preto, São Paulo, Brazil
Contact: Diocésio de Andrade, MD         
Instituto Nacional do Câncer Recruiting
Rio de Janeiro, Brazil
Contact: José Bines, MD         
Oncoclínica Recruiting
Rio de Janeiro, Brazil
Contact: Susanne Crocamo, MD         
Centro de Pesquisa Clínica do Hospital Israelita Albert Einstein Recruiting
São Paulo, Brazil
Contact: Sérgio Simon, MD         
Centro de Pesquisa Instituto do Câncer Arnaldo Vieira de Carvalho Recruiting
São Paulo, Brazil
Contact: Brigitte Van Eyil, MD         
Hospital AC Camargo Recruiting
São Paulo, Brazil
Contact: Vladmir Lima, MD         
Sponsors and Collaborators
Latin American Cooperative Oncology Group
Ministry of Health, Brazil
Avon Institute
Investigators
Study Director: Gustavo Werutsky, MD Latin American Cooperative Oncology Group
  More Information

Additional Information:
Publications:
Lohman TG, Roche AF, Martorell R. Anthropometric standardization reference manual. Illinois: A division of human Kinetics Publishers Inc, 1988.

Responsible Party: Latin American Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT02663973     History of Changes
Other Study ID Numbers: GBECAM 0115
First Submitted: January 19, 2016
First Posted: January 26, 2016
Last Update Posted: February 24, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Latin American Cooperative Oncology Group:
Breast cancer

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