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

NCT ID: NCT07167433

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-19

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ovarian Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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);
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Porto Alegre, , Brazil

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

AstraZeneca Clinical Study Information Center

Role: CONTACT

Phone: 1-877-240-9479

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D133HR00051

Identifier Type: -

Identifier Source: org_study_id