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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Description of socio-demographic characteristics | 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. | Throught study a completation, an average of 3 years |
| Description of pathological characteristics | 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. | Throught study a completation, an average of 3 years |
| Description of treatment | 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. | Throught study a completation, an average of 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment interval of systemic therapy in metastatic disease | 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. |
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Inclusion Criteria:
Exclusion Criteria:
The study base consists of patients newly diagnosed with ovarian cancer across stages IA to IVB, and those with persistent or recurrent disease, diagnosed from January 2021 onwards. The study will span 20 research sites across diverse geographical locations, ensuring a broad representation of different healthcare settings and patient demographics. The study population will include patients aged 18 years and older, irrespective of histological subtype. Over a 12-month enrollment period, a total of 250 patients are expected to be included in the study. The follow-up period will extend for 3 years, with data collection occurring at 12, 24, and 36 months.
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The study base consists of patients newly diagnosed with ovarian cancer across stages IA to IVB, and those with persistent or recurrent disease, diagnosed from January 2021 onwards.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Barretos | Brazil | |||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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| Throught study a completation, an average of 3 years |
| Disease free-survival | 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. | Throught study a completation, an average of 3 years |
| Time to next chemotherapy | 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. | Throught study a completation, an average of 3 years |
| Recruiting |
| Belo Horizonte |
| Brazil |
| Research Site | Active, not recruiting | Belo Horizonte | Brazil |
| Research Site | Recruiting | Brasília | Brazil |
| Research Site | Active, not recruiting | Curitiba | Brazil |
| Research Site | Recruiting | Goiânia | Brazil |
| Research Site | Active, not recruiting | João Pessoa | Brazil |
| Research Site | Recruiting | Natal | Brazil |
| Research Site | Recruiting | Porto Alegre | Brazil |
| Research Site | Active, not recruiting | Porto Alegre | Brazil |
| Research Site | Active, not recruiting | Recife | Brazil |
| Research Site | Active, not recruiting | Rio Branco | Brazil |
| Research Site | Recruiting | Rio de Janeiro | Brazil |
| Research Site | Recruiting | Salvador | Brazil |
| Research Site | Recruiting | São Jose Dos Campos | Brazil |
| Research Site | Recruiting | São Paulo | Brazil |
| Research Site | Not yet recruiting | São Paulo | Brazil |
| Research Site | Active, not recruiting | São Paulo | Brazil |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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