Prospective Evaluation of Patients With Uterine Cervical Cancer in

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02671071
Study type	Observational [Patient Registry]
Source	Latin American Cooperative Oncology Group
Contact
Status	Completed
Phase
Start date	April 2016
Completion date	December 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms