Cervix Cancer
Conditions
Keywords
Cervix Cancer
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.
Interventions
BEHAVIORALQuality 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.
Sponsors
EVA - Grupo Brasileiro de Tumores Ginecológicos
Roche Pharma AG
Latin American Cooperative Oncology Group
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Characterization of cervix cancer in the Brazilian female population | 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 | — |
| Socio-demographic characteristics of the female population diagnosed with CC | Month 0 (beginning of the study) | — |
| 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 | — |
| Number of patients with disease overall survival | Month 3, 6, 12, 24 and 36 | — |
Countries
Brazil
Outcome results
None listed