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临床试验/NCT02671071
NCT02671071已完成不适用

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

Latin American Cooperative Oncology Group16 个研究点 分布在 1 个国家目标入组 638 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
638
试验地点
16
主要终点
Characterization of cervix cancer in the Brazilian female population

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Characterization of cervix cancer in the Brazilian female population

时间窗: 3 years

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (16)

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