NCT02671071已完成不适用
Prospective Evaluation of Patients With Uterine Cervical Cancer in Brazilian Health Institutions - The EVITA I Study
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
- 否
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
研究点 (16)
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