Ovarian Cancer Epidemiology and Care in Brazil: A Multicenter Perspective (OLIVIA Study) Observational, Bi-directional (Prospective and Retrospective) Study for Patients With Newly Diagnosed Ovarian Cancer Stages IA to IVB, or Persistent or Recurrent Disease From January 2021; Irrespective of Histology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 250
- 试验地点
- 33
- 主要终点
- Description of socio-demographic characteristics
研究概览
简要总结
The findings from this study have the potential to serve as a foundation for evaluating the current practices related to surgical procedures, systemic therapies, hyperthermic intraperitoneal chemotherapy, and referrals to geneticists for OC patients. By identifying the strengths and weaknesses of the existing care, this project intends to generate valuable insights that can lead to the implementation of quality parameters for the treatment of ovarian cancer in the country.
详细描述
This study is an observational, bi-directional (prospective and retrospective) analytical study designed to assess the sociodemographic, clinical, and pathological characteristics of patients with ovarian cancer, stages IA to IVB, as well as those with persistent or recurrent disease. The study will include 250 patients who meet the eligibility criteria of being 18 years or older, with a diagnosis of ovarian cancer from January 2021, irrespective of histology, over a 1-year enrollment period across 20 participating sites.
Upon enrollment, baseline data will be collected, which includes sociodemographic details, clinical information, pathological findings, and genetic testing and counseling data. Follow-up data will be gathered at 12, 24, and 36 months to monitor treatment patterns and outcomes. These data collection points will allow for the evaluation of both short-term and long-term outcomes, providing valuable insights into the progression and management of ovarian cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years old;
- •Newly diagnosed ovarian cancer stages IA to IVB, or persistent or recurrent disease from January 2021;
- •Irrespective of histology
排除标准
- •Borderline tumors;
- •Pregnancy;
- •Synchronous tumor or second primary in the last 5 years (except thyroid cancer and non-melanoma skin cancer);
研究组 & 干预措施
Group 1
patients newly diagnosed with ovarian cancer across stages IA to IVB, and those with persistent or recurrent disease, diagnosed from January 2021 onwards
结局指标
主要结局
Description of socio-demographic characteristics
时间窗: Throught study a completation, an average of 3 years
The study's findings could provide a basis for evaluating current practices in ovarian treatment and other characteristics about this disease. By identifying strengths and weaknesses in existing care, the project aims to offer insights that may lead to the implementation of quality parameters for ovarian cancer treatment in the country. No formal statistical comparisons are begin performed for the primary outcomes of this study.
Description of pathological characteristics
时间窗: Throught study a completation, an average of 3 years
The study's findings could provide a basis for evaluating current practices in ovarian treatment and other characteristics about this disease. By identifying strengths and weaknesses in existing care, the project aims to offer insights that may lead to the implementation of quality parameters for ovarian cancer treatment in the country. No formal statistical comparisons are being performed for the primary outcomes of this study.
Description of treatment
时间窗: Throught study a completation, an average of 3 years
The study's findings could provide a basis for evaluating current practices in ovarian treatment and other characteristics about this disease. By identifying strengths and weaknesses in existing care, the project aims to offer insights that may lead to the implementation of quality parameters for ovarian cancer treatment in the country. No formal statistical comparisons are being performed for the primary outcomes of this study.
次要结局
- Treatment interval of systemic therapy in metastatic disease(Throught study a completation, an average of 3 years)
- Disease free-survival(Throught study a completation, an average of 3 years)
- Time to next chemotherapy(Throught study a completation, an average of 3 years)