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Clinical Trials/NCT02671071
NCT02671071
Completed
Not Applicable

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

Latin American Cooperative Oncology Group16 sites in 1 country638 target enrollmentApril 2016
ConditionsCervix Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cervix Cancer
Sponsor
Latin American Cooperative Oncology Group
Enrollment
638
Locations
16
Primary Endpoint
Characterization of cervix cancer in the Brazilian female population
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
December 2021
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility 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

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

Outcomes

Primary Outcomes

Characterization of cervix cancer in the Brazilian female population

Time Frame: 3 years

Secondary Outcomes

  • Number of patients with progression survival(Month 3, 6, 12, 24 and 36)
  • Socio-demographic characteristics of the female population diagnosed with CC(Month 0 (beginning of the study))
  • Number of patients with disease survival(Month 3, 6, 12, 24 and 36)
  • Number of patients with overall survival(Month 3, 6, 12, 24 and 36)
  • Number of patients with disease overall survival(Month 3, 6, 12, 24 and 36)
  • Duration of treatment after the diagnosis of cervix cancer(Month 0, 3, 6,12, 24 and 36)
  • Description of the method used to diagnose the brazillian female patients with cervix cancer(Month 0)
  • The clinical and pathological characteristics of cervix cancer in brazilian female patients(Month 0)
  • Type of treatment assessed in patients with CC(Month 0, 3, 6,12, 24 and 36)
  • Type and description of the indicated treatment after the diagnosis of cervix cancer in brazilian female patients(Month 0, 3, 6,12, 24 and 36)
  • Description of adverse effects of the cervix cancer treatment(Month 0, 3, 6,12, 24 and 36)
  • Number of adverse effects of the cervix cancer treatment(Month 0, 3, 6,12, 24 and 36)
  • Type of clinical outcomes of the patients with cervix cancer in Brazil(Month 0, 3, 6,12, 24 and 36)

Study Sites (16)

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