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Recruiting NCT07167433

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

— Observational Ovarian Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Ovarian Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Ovarian Cancer Epidemiology and Care in Brazil: A Multicenter Perspective (OLIVIA Study) 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

Overview

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.

Primary outcome measures

  • Description of socio-demographic characteristics [Time frame: Throught study a completation, an average of 3 years]
  • Description of pathological characteristics [Time frame: Throught study a completation, an average of 3 years]
  • Description of treatment [Time frame: Throught study a completation, an average of 3 years]
Secondary outcome measures (3)
  • Treatment interval of systemic therapy in metastatic disease [Time frame: Throught study a completation, an average of 3 years]
  • Disease free-survival [Time frame: Throught study a completation, an average of 3 years]
  • Time to next chemotherapy [Time frame: Throught study a completation, an average of 3 years]

Eligibility criteria

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);

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Brazil · 15 centers
  • Research Site — Barretos/SP
  • Research Site — Belo Horizonte/MG
  • Research Site — Bras lia/DF
  • Research Site — Curitiba/PR
  • Research Site — Goi nia/GO
  • Research Site — Joao Pessoa/PB
  • Research Site — Natal/RN
  • Research Site — Porto Alegre/RS
  • … and 7 more centers

Identifiers

NCT: NCT07167433 · D133HR00051

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗