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

December 23, 2021 updated by: Latin American Cooperative Oncology Group
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

638

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil
        • INCA
      • Sao Paulo, Brazil
        • Hospital Sao Jose
      • São Paulo, Brazil
        • Instituto Brasileiro de Controle do Cancer - ibcc
    • Amazonas
      • Manaus, Amazonas, Brazil
        • Fundação Centro de Controle do Câncer do Estado do Amazonas
    • Bahia
      • Salvador, Bahia, Brazil
        • Clinica AMO
    • Ceará
      • Fortaleza, Ceará, Brazil
        • CRIO
    • Fortaleza
      • Ceara, Fortaleza, Brazil, CE
        • HU Walter Cantídeo
    • Maranhão
      • Sao Luis, Maranhão, Brazil
        • Hospital Alderona Bello
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil
        • UFMG
    • Paraná
      • Curitiba, Paraná, Brazil
        • Hospital Erasto Gaertner
    • Pernambuco
      • Recife, Pernambuco, Brazil
        • IMIP
    • Rio Grande Do Sul
      • Passo Fundo, Rio Grande Do Sul, Brazil
        • Hospital Sao Vicente de Paulo
      • Porto Alegre, Rio Grande Do Sul, Brazil
        • CPO - Hsl/Pucrs
    • Roraima
      • Boa Vista, Roraima, Brazil
        • Hospital Geral de Roraima
    • Santa Catarina
      • Florianopolis, Santa Catarina, Brazil
        • CEPON
      • Itajaí, Santa Catarina, Brazil
        • Centro de Novos Tratamentos Litoral - Itajaí

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Characterization of cervix cancer in the Brazilian female population
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Socio-demographic characteristics of the female population diagnosed with CC
Time Frame: Month 0 (beginning of the study)
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
Month 0
The clinical and pathological characteristics of cervix cancer in brazilian female patients
Time Frame: Month 0
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
Month 0, 3, 6,12, 24 and 36
Number of patients with disease survival
Time Frame: Month 3, 6, 12, 24 and 36
Month 3, 6, 12, 24 and 36
Number of patients with progression survival
Time Frame: Month 3, 6, 12, 24 and 36
Month 3, 6, 12, 24 and 36
Number of patients with overall survival
Time Frame: Month 3, 6, 12, 24 and 36
Month 3, 6, 12, 24 and 36
Number of patients with disease overall survival
Time Frame: Month 3, 6, 12, 24 and 36
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
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
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
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
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
Month 0, 3, 6,12, 24 and 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Latin American Cooperative Oncology Group

Collaborators

Roche Pharma AG
EVA - Grupo Brasileiro de Tumores Ginecológicos

Investigators

  • Study Director: Gustavo Werutsky, MD, Latin American Cooperative Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

January 15, 2016

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimate)

February 2, 2016

Study Record Updates

Last Update Posted (Actual)

December 27, 2021

Last Update Submitted That Met QC Criteria

December 23, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LACOG 0215/EVA 001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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