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Completed

NCT Number: NCT02671071

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Fundação Centro de Controle do Câncer do Estado do Amazonas, Manaus, Amazonas, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Quality of Life Questionnaire (QLQ)

Behavioral

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.

Primary outcomes

  1. Characterization of cervix cancer in the Brazilian female population

    Time frame: 3 years

Secondary outcomes

  1. Socio-demographic characteristics of the female population diagnosed with CC

    Time frame: Month 0 (beginning of the study)

  2. 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

  3. The clinical and pathological characteristics of cervix cancer in brazilian female patients

    Time frame: Month 0

  4. Type of treatment assessed in patients with CC

    Time frame: Month 0, 3, 6,12, 24 and 36

    Radiotherapy, Chemotherapy and/or Surgery

  5. Number of patients with disease survival

    Time frame: Month 3, 6, 12, 24 and 36

  6. Number of patients with progression survival

    Time frame: Month 3, 6, 12, 24 and 36

  7. Number of patients with overall survival

    Time frame: Month 3, 6, 12, 24 and 36

  8. Number of patients with disease overall survival

    Time frame: Month 3, 6, 12, 24 and 36

  9. 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

  10. Duration of treatment after the diagnosis of cervix cancer

    Time frame: Month 0, 3, 6,12, 24 and 36

  11. Description of adverse effects of the cervix cancer treatment

    Time frame: Month 0, 3, 6,12, 24 and 36

  12. Number of adverse effects of the cervix cancer treatment

    Time frame: Month 0, 3, 6,12, 24 and 36

  13. Type of clinical outcomes of the patients with cervix cancer in Brazil

    Time frame: Month 0, 3, 6,12, 24 and 36

Sponsors and collaborators

Lead sponsor

Latin American Cooperative Oncology Group

Other

Collaborators

  • EVA - Grupo Brasileiro de Tumores Ginecológicos
  • Roche Pharma AG

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Feb 2, 2016
Registry last updated
Dec 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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