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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 São José
      • São Paulo, Brazil
        • Instituto Brasileiro De Controle Do Câncer - IBCC
    • Amazonas
      • Manaus, Amazonas, Brazil
        • Fundação Centro de Controle do Câncer do Estado do Amazonas
    • Bahia
      • Salvador, Bahia, Brazil
        • Clínica 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 São 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Characterization of cervix cancer in the Brazilian female population
Time Frame: 3 years
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Latin American Cooperative Oncology Group

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Roche Pharma AG
EVA - Grupo Brasileiro de Tumores Ginecológicos

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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