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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671071
Recruitment Status : Active, not recruiting
First Posted : February 2, 2016
Last Update Posted : February 19, 2020
Sponsor:
Collaborators:
EVA - Grupo Brasileiro de Tumores Ginecológicos
Roche Pharma AG
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Cervix Cancer Behavioral: Quality of Life Questionnaire (QLQ)

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Prospective Evaluation of Patients With Uterine Cervical Cancer in Brazilian Health Institutions - The EVITA I Study
Study Start Date : April 2016
Actual Primary Completion Date : October 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer


Intervention Details:
  • Behavioral: Quality of Life Questionnaire (QLQ)
    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.


Primary Outcome Measures :
  1. Characterization of cervix cancer in the Brazilian female population [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Socio-demographic characteristics of the female population diagnosed with CC [ Time Frame: Month 0 (beginning of the study) ]
  2. Description of the method used to diagnose the brazillian female patients with cervix cancer [ Time Frame: Month 0 ]
    Screening tests (Papanicolaou test) or symptoms presented by patients

  3. The clinical and pathological characteristics of cervix cancer in brazilian female patients [ Time Frame: Month 0 ]
  4. Type of treatment assessed in patients with CC [ Time Frame: Month 0, 3, 6,12, 24 and 36 ]
    Radiotherapy, Chemotherapy and/or Surgery

  5. Number of patients with disease survival [ Time Frame: Month 3, 6, 12, 24 and 36 ]
  6. Number of patients with progression survival [ Time Frame: Month 3, 6, 12, 24 and 36 ]
  7. Number of patients with overall survival [ Time Frame: Month 3, 6, 12, 24 and 36 ]
  8. Number of patients with disease overall survival [ Time Frame: Month 3, 6, 12, 24 and 36 ]
  9. Type and description of the indicated treatment after the diagnosis of cervix cancer in brazilian female patients [ Time Frame: Month 0, 3, 6,12, 24 and 36 ]
  10. Duration of treatment after the diagnosis of cervix cancer [ Time Frame: Month 0, 3, 6,12, 24 and 36 ]
  11. Description of adverse effects of the cervix cancer treatment [ Time Frame: Month 0, 3, 6,12, 24 and 36 ]
  12. Number of adverse effects of the cervix cancer treatment [ Time Frame: Month 0, 3, 6,12, 24 and 36 ]
  13. Type of clinical outcomes of the patients with cervix cancer in Brazil [ Time Frame: Month 0, 3, 6,12, 24 and 36 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671071


Locations
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Brazil
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, CE
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
Sponsors and Collaborators
Latin American Cooperative Oncology Group
EVA - Grupo Brasileiro de Tumores Ginecológicos
Roche Pharma AG
Investigators
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Study Director: Gustavo Werutsky, MD Latin American Cooperative Oncology Group
Additional Information:

Publications:
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Responsible Party: Latin American Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT02671071    
Other Study ID Numbers: LACOG 0215/EVA 001
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Keywords provided by Latin American Cooperative Oncology Group:
Cervix Cancer
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female