Prospective Evaluation of Patients With Uterine Cervical Cancer in Brazilian Health Institutions - The EVITA I Study
- Conditions
- Cervix Cancer
- Registration Number
- NCT02671071
- Lead Sponsor
- Latin American Cooperative Oncology Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 638
- Histologic confirmed invasive cervical cancer
- Diagnosis of FIGO stages
- Stage 1B to 2A high risk
- 2B-4B or recurrent disease
- Patients ≥18 years old
- Non-invasive uterine carcinoma;
- Pregnancy;
- synchronous tumor or second primary tumor in the past 5 years (except thyreoid ancer or non-melanoma skin cancer).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Characterization of cervix cancer in the Brazilian female population 3 years
- Secondary Outcome Measures
Name Time Method 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 Screening tests (Papanicolaou test) or symptoms presented by patients
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 Radiotherapy, Chemotherapy and/or Surgery
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
Trial Locations
- Locations (16)
HU Walter Cantídeo
🇧🇷Ceara, Fortaleza, Brazil
Hospital Erasto Gaertner
🇧🇷Curitiba, Paraná, Brazil
CRIO
🇧🇷Fortaleza, Ceará, Brazil
INCA
🇧🇷Rio de Janeiro, Brazil
Instituto Brasileiro de Controle do Câncer - IBCC
🇧🇷São Paulo, Brazil
Hospital São José
🇧🇷Sao Paulo, Brazil
UFMG
🇧🇷Belo Horizonte, Minas Gerais, Brazil
CEPON
🇧🇷Florianopolis, Santa Catarina, Brazil
Clínica AMO
🇧🇷Salvador, Bahia, Brazil
Hospital São Vicente de Paulo
🇧🇷Passo Fundo, Rio Grande Do Sul, Brazil
CPO - Hsl/Pucrs
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
IMIP
🇧🇷Recife, Pernambuco, Brazil
Fundação Centro de Controle do Câncer do Estado do Amazonas
🇧🇷Manaus, Amazonas, Brazil
Centro de Novos Tratamentos Litoral - Itajaí
🇧🇷Itajaí, Santa Catarina, Brazil
Hospital Alderona Bello
🇧🇷Sao Luis, Maranhão, Brazil
Hospital Geral de Roraima
🇧🇷Boa Vista, Roraima, Brazil