Spots Global Cancer Trial Database for Prospective Evaluation of Patients With Uterine Cervical Cancer in Brazilian Health Institutions - The EVITA I Study
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Trial Identification
Brief Title: Prospective Evaluation of Patients With Uterine Cervical Cancer in Brazilian Health Institutions - The EVITA I Study
Official Title: Prospective Evaluation of Patients With Uterine Cervical Cancer in Brazilian Health Institutions - The EVITA I Study
Study ID: NCT02671071
Conditions
Interventions
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Fundação Centro de Controle do Câncer do Estado do Amazonas, Manaus, Amazonas, Brazil
Clínica AMO, Salvador, Bahia, Brazil
CRIO, Fortaleza, Ceará, Brazil
HU Walter Cantídeo, Ceara, Fortaleza, Brazil
Hospital Alderona Bello, Sao Luis, Maranhão, Brazil
UFMG, Belo Horizonte, Minas Gerais, Brazil
Hospital Erasto Gaertner, Curitiba, Paraná, Brazil
IMIP, Recife, Pernambuco, Brazil
Hospital São Vicente de Paulo, Passo Fundo, Rio Grande Do Sul, Brazil
CPO - Hsl/Pucrs, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Geral de Roraima, Boa Vista, Roraima, Brazil
CEPON, Florianopolis, Santa Catarina, Brazil
Centro de Novos Tratamentos Litoral - Itajaí, Itajaí, Santa Catarina, Brazil
INCA, Rio de Janeiro, , Brazil
Hospital São José, Sao Paulo, , Brazil
Instituto Brasileiro de Controle do Câncer - IBCC, São Paulo, , Brazil
Contact Details
Name: Gustavo Werutsky, MD
Affiliation: Latin American Cooperative Oncology Group
Role: STUDY_DIRECTOR
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