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

NCT07167433 | Recruiting

• 1 other identifier: D133HR00051
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 13

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• 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

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Patients ≥18 years old;
• Newly diagnosed ovarian cancer stages IA to IVB, or persistent or recurrent disease from January 2021;
• Irrespective of histology

You may not qualify if:

• Borderline tumors;
• Pregnancy;
• Synchronous tumor or second primary in the last 5 years (except thyroid cancer and non-melanoma skin cancer);

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (13)

Research Site

Barretos, Brazil

RECRUITING

Research Site

Belo Horizonte, Brazil

RECRUITING

Research Site

Belo Horizonte, Brazil

NOT YET RECRUITING

Research Site

Brasília, Brazil

RECRUITING

Research Site

Goiânia, Brazil

RECRUITING

Research Site

Natal, Brazil

RECRUITING

Research Site

Porto Alegre, Brazil

RECRUITING

Research Site

Porto Alegre, Brazil

NOT YET RECRUITING

Research Site

Recife, Brazil

NOT YET RECRUITING

Research Site

Rio de Janeiro, Brazil

RECRUITING

Research Site

Salvador, Brazil

RECRUITING

Research Site

São Jose Dos Campos, Brazil

RECRUITING

Research Site

São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: September 11, 2025
• Study Start: September 19, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: 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.
• Access Criteria: 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.

Locations

BR (13)