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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervix Cancer

Intervention / Treatment
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* Behavioral: Quality of Life Questionnaire (QLQ)


Participation Criteria
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Eligibility Criteria
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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: Non-invasive uterine carcinoma; Pregnancy; synchronous tumor or second primary tumor in the past 5 years (except thyreoid ancer or non-melanoma skin cancer).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of cervix cancer in the Brazilian female population |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Screening tests (Papanicolaou test) or symptoms presented by patients | Month 0 | 
| The clinical and pathological characteristics of cervix cancer in brazilian female patients |  | Month 0 | 
| Type of treatment assessed in patients with CC | Radiotherapy, Chemotherapy and/or Surgery | Month 0, 3, 6,12, 24 and 36 | 
| Number of patients with disease survival |  | Month 3, 6, 12, 24 and 36 | 
| Number of patients with progression 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 | 
| 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 | 
| Duration of treatment after the diagnosis of cervix cancer |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervix Cancer