Prospective Evaluation of Patients With Uterine Cervical Cancer in Brazilian Health Institutions - The EVITA I Study
1 other identifier
observational
638
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2016
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2016
CompletedFirst Posted
Study publicly available on registry
February 2, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedDecember 27, 2021
December 1, 2021
4.7 years
January 15, 2016
December 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Characterization of cervix cancer in the Brazilian female population
3 years
Secondary Outcomes (13)
Socio-demographic characteristics of the female population diagnosed with CC
Month 0 (beginning of the study)
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
Number of patients with disease survival
Month 3, 6, 12, 24 and 36
- +8 more secondary outcomes
Interventions
The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Cervical cancer module (EORTC QLQ-CX24) will be applied to all patients at 0, 3, 6, 12, 24, 36 months.
Eligibility Criteria
Patients diagnosed with cervical cancer in 1-year period (recently diagnosed IB to IIA high risk or IIB-IVB or recurrent disease - FIGO stages) at the participating sites will be included in the study.
You may qualify if:
- Histologic confirmed invasive cervical cancer
- Diagnosis of FIGO stages
- Stage 1B to 2A high risk
- B-4B or recurrent disease
- Patients ≥18 years old
You may not qualify if:
- Non-invasive uterine carcinoma;
- Pregnancy;
- synchronous tumor or second primary tumor in the past 5 years (except thyreoid ancer or non-melanoma skin cancer).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Latin American Cooperative Oncology Grouplead
- EVA - Grupo Brasileiro de Tumores Ginecológicoscollaborator
- Roche Pharma AGcollaborator
Study Sites (16)
Fundação Centro de Controle do Câncer do Estado do Amazonas
Manaus, Amazonas, Brazil
CRIO
Fortaleza, Ceará, Brazil
Clínica AMO
Salvador, Estado de Bahia, Brazil
HU Walter Cantídeo
Ceará, Fortaleza, CE, Brazil
Hospital Alderona Bello
São Luís, 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
Florianópolis, Santa Catarina, Brazil
Centro de Novos Tratamentos Litoral - Itajaí
Itajaí, Santa Catarina, Brazil
INCA
Rio de Janeiro, Brazil
Hospital São José
São Paulo, Brazil
Instituto Brasileiro de Controle do Câncer - IBCC
São Paulo, Brazil
Related Publications (6)
Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
PMID: 21296855BACKGROUNDMunoz N, Franco EL, Herrero R, Andrus JK, de Quadros C, Goldie SJ, Bosch FX. Recommendations for cervical cancer prevention in Latin America and the Caribbean. Vaccine. 2008 Aug 19;26 Suppl 11:L96-L107. doi: 10.1016/j.vaccine.2008.05.062.
PMID: 18945407BACKGROUNDHellner K, Munger K. Human papillomaviruses as therapeutic targets in human cancer. J Clin Oncol. 2011 May 1;29(13):1785-94. doi: 10.1200/JCO.2010.28.2186. Epub 2011 Jan 10.
PMID: 21220591BACKGROUNDMartinez-Mesa J, Werutsky G, Campani RB, Wehrmeister FC, Barrios CH. Inequalities in Pap smear screening for cervical cancer in Brazil. Prev Med. 2013 Oct;57(4):366-71. doi: 10.1016/j.ypmed.2013.06.026. Epub 2013 Jul 1.
PMID: 23827721BACKGROUNDZuliani AC, Esteves SC, Teixeira LC, Teixeira JC, de Souza GA, Sarian LO. Concomitant cisplatin plus radiotherapy and high-dose-rate brachytherapy versus radiotherapy alone for stage IIIB epidermoid cervical cancer: a randomized controlled trial. J Clin Oncol. 2014 Feb 20;32(6):542-7. doi: 10.1200/JCO.2013.50.1205. Epub 2014 Jan 21.
PMID: 24449243BACKGROUNDPearcey R, Brundage M, Drouin P, Jeffrey J, Johnston D, Lukka H, MacLean G, Souhami L, Stuart G, Tu D. Phase III trial comparing radical radiotherapy with and without cisplatin chemotherapy in patients with advanced squamous cell cancer of the cervix. J Clin Oncol. 2002 Feb 15;20(4):966-72. doi: 10.1200/JCO.2002.20.4.966.
PMID: 11844818BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gustavo Werutsky, MD
Latin American Cooperative Oncology Group
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2016
First Posted
February 2, 2016
Study Start
April 1, 2016
Primary Completion
December 1, 2020
Study Completion
December 1, 2021
Last Updated
December 27, 2021
Record last verified: 2021-12