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

Not yet recruiting

• Conditions: Ovarian Cancer

• Registration Number: NCT07167433
• Lead Sponsor: AstraZeneca

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.

Study Timeline

• Study First Submitted: 2025-08-18
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-09
• Last Update Submitted: 2025-09-09
• Study First Posted: 2025-09-11
• Last Update Posted: 2025-09-11
• Study Start: 2025-09-30
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 250

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);

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.