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Prospective Evaluation of Patients With Uterine Cervical Cancer in Brazilian Health Institutions - The EVITA I Study

This study is currently recruiting participants.
Verified February 2017 by Latin American Cooperative Oncology Group
Sponsor:
ClinicalTrials.gov Identifier:
NCT02671071
First Posted: February 2, 2016
Last Update Posted: February 23, 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:
EVA - Grupo Brasileiro de Tumores Ginecológicos
Roche Pharma AG
Information provided by (Responsible Party):
Latin American Cooperative Oncology Group
  Purpose
The primary objective of this study is to describe the socio-demographic, clinical pathological, quality of life and treatment characteristics of patients diagnosed with CC in Brazil.

Condition Intervention
Cervix Cancer Behavioral: Quality of Life Questionnaire (QLQ)

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Prospective Evaluation of Patients With Uterine Cervical Cancer in Brazilian Health Institutions - The EVITA I Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Characterization of cervix cancer in the Brazilian female population [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Socio-demographic characteristics of the female population diagnosed with CC [ Time Frame: Month 0 (beginning of the study) ]
  • Description of the method used to diagnose the brazillian female patients with cervix cancer [ Time Frame: Month 0 ]
    Screening tests (Papanicolaou test) or symptoms presented by patients

  • The clinical and pathological characteristics of cervix cancer in brazilian female patients [ Time Frame: Month 0 ]
  • Type of treatment assessed in patients with CC [ Time Frame: Month 0, 3, 6,12, 24 and 36 ]
    Radiotherapy, Chemotherapy and/or Surgery

  • Number of patients with disease survival [ Time Frame: Month 3, 6, 12, 24 and 36 ]
  • Number of patients with progression survival [ Time Frame: Month 3, 6, 12, 24 and 36 ]
  • Number of patients with overall survival [ Time Frame: Month 3, 6, 12, 24 and 36 ]
  • Number of patients with disease overall survival [ Time Frame: Month 3, 6, 12, 24 and 36 ]
  • Type and description of the indicated treatment after the diagnosis of cervix cancer in brazilian female patients [ Time Frame: Month 0, 3, 6,12, 24 and 36 ]
  • Duration of treatment after the diagnosis of cervix cancer [ Time Frame: Month 0, 3, 6,12, 24 and 36 ]
  • Description of adverse effects of the cervix cancer treatment [ Time Frame: Month 0, 3, 6,12, 24 and 36 ]
  • Number of adverse effects of the cervix cancer treatment [ Time Frame: Month 0, 3, 6,12, 24 and 36 ]
  • Type of clinical outcomes of the patients with cervix cancer in Brazil [ Time Frame: Month 0, 3, 6,12, 24 and 36 ]

Estimated Enrollment: 800
Study Start Date: April 2016
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Quality of Life Questionnaire (QLQ)
    The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Cervical cancer module (EORTC QLQ-CX24) will be applied to all patients at 0, 3, 6, 12, 24, 36 months.
Detailed Description:

The primary objective of this study is to describe the socio-demographic, clinical pathological, quality of life and treatment characteristics of patients diagnosed with cervix cancer (CC) in Brazil. Other specific objectives are:

  • To describe socio-demographic characteristics: age at diagnosis, education, family income, race, occupation, personal health habits - e.g.oral contraceptive use ever/never and duration; smoking never/ever/current/duration , ever drinking), sexual history, insurance coverage (private, public), institution (private, public, philanthropic), obstetric history, comorbidities, performance status, human papillomavirus vaccination or not
  • To describe the screening for CC: access, type, frequency and results.
  • To describe clinical pathological characteristics of CC: histology (adeno x squamous x adenosquamous x neuroendocrine x other) , International Federation of Gynecology and Obstetrics (FIGO) stage, pathological stage, exams for staging, date of diagnosis, site of metastasis.
  • To describe treatment characteristics of CC: date of surgery, type of surgery; date and duration of radiotherapy, type of radiotherapy; date, type and lines of systemic therapy (chemotherapy, monoclonal antibodies),
  • To describe treatment safety (grade 3-4 AEs, death due to treatment toxicity, discontinuation due to AE). In addition adverse events of special interest will be described (details on Safety section).
  • To describe the outcomes: follow-up exams and date of visits, persistent disease, recurrence, progression times in metastatic disease, complications (e.g. hydronephrosis/nephrostomy/ GI perforations and both GI & genitourinary fistulae.), death due CC and death from any cause.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Patients diagnosed with cervical cancer in 1-year period (recently diagnosed IB to IIA high risk or IIB-IVB or recurrent disease - FIGO stages) at the participating sites will be included in the study.
Criteria

Inclusion Criteria:

  • Histologic confirmed invasive cervical cancer
  • Diagnosis of FIGO stages
  • Stage 1B to 2A high risk
  • 2B-4B or recurrent disease
  • Patients ≥18 years old

Exclusion Criteria:

  1. Non-invasive uterine carcinoma;
  2. Pregnancy;
  3. synchronous tumor or second primary tumor in the past 5 years (except thyreoid ancer or non-melanoma skin cancer).
  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): NCT02671071


Contacts
Contact: Laura Voelcker 55 51 3384 5334 laura.voelcker@lacog.org.br
Contact: Raíra Maschmann 55 51 3384 5334 raira.maschmann@lacog.org.br

Locations
Brazil
Fundação Centro de Controle do Câncer do Estado do Amazonas Recruiting
Manaus, Amazonas, Brazil
Contact: Kátia Torres, PhD         
Principal Investigator: Kátia Torres, PhD         
Clínica AMO Recruiting
Salvador, Bahia, Brazil
Contact: Isabela Almeida         
Principal Investigator: Aknar Calabrich, MD         
CRIO Recruiting
Fortaleza, Ceará, Brazil
Contact: Monica Gomes         
Principal Investigator: Eduardo Cronenberger, MD         
Hospital Alderona Bello Recruiting
Sao Luis, Maranhão, Brazil
Contact: Alice Parentes         
Principal Investigator: Rachel Cossetti, MD         
UFMG Recruiting
Belo Horizonte, Minas Gerais, Brazil
Contact: Gabriela Marinho         
Principal Investigator: Angélica Rodrigues, MD         
Hospital Erasto Gaertner Recruiting
Curitiba, Paraná, Brazil
Contact: Taís Bisetto         
Principal Investigator: João Nunes         
IMIP Recruiting
Recife, Pernambuco, Brazil
Contact: Danielle Menor         
Principal Investigator: Carla Rameri, MD         
Hospital São Vicente de Paulo Recruiting
Passo Fundo, Rio Grande do Sul, Brazil
Contact: Nincia Kaross         
Principal Investigator: Felipe Thomé, MD         
CPO - Hsl/Pucrs Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Contact: Virginia Webber         
Principal Investigator: Fernanda Damian, MD         
Hospital Geral de Roraima Recruiting
Boa Vista, Roraima, Brazil
Contact: Allex Jardim, MD         
Principal Investigator: Allex Jardim, MD         
CEPON Recruiting
Florianopolis, Santa Catarina, Brazil
Contact: Camila Sommer         
Contact: Camila Donadel         
Principal Investigator: Lizana Arend, MD         
Centro de Novos Tratamentos Litoral - Itajaí Recruiting
Itajaí, Santa Catarina, Brazil
Contact: Karyn Maman         
Principal Investigator: Giuliano Borges, MD         
INCA Recruiting
Rio de Janeiro, Brazil
Contact: Bruno Baldino         
Principal Investigator: Andréia Melo, MD         
Hospital São José Recruiting
Sao Paulo, Brazil
Contact: Daniel Lang         
Principal Investigator: Fernando Maluf, MD         
Instituto Brasileiro de Controle do Câncer - IBCC Recruiting
São Paulo, Brazil
Contact: Juliana Mauri         
Principal Investigator: André Lopes, MD         
Sponsors and Collaborators
Latin American Cooperative Oncology Group
EVA - Grupo Brasileiro de Tumores Ginecológicos
Roche Pharma AG
Investigators
Study Director: Gustavo Werutsky, MD Latin American Cooperative Oncology Group
  More Information

Publications:
Responsible Party: Latin American Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT02671071     History of Changes
Other Study ID Numbers: LACOG 0215/EVA 001
First Submitted: January 15, 2016
First Posted: February 2, 2016
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Latin American Cooperative Oncology Group:
Cervix Cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female