Ovarian Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥18 years old; * Newly diagnosed ovarian cancer stages IA to IVB, or persistent or recurrent disease from January 2021; * Irrespective of histology
Exclusion criteria
* Borderline tumors; * Pregnancy; * Synchronous tumor or second primary in the last 5 years (except thyroid cancer and non-melanoma skin cancer);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Description of socio-demographic characteristics | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment interval of systemic therapy in metastatic disease | 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 beign performed for the outcomes of this study. |
| Disease free-survival | 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 beign performed for the outcomes of this study. |
| Time to next chemotherapy | 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 beign performed for the outcomes of this study. |
Countries
Brazil
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed