Ovarian Cancer Registry (OVAR); A study protocol for retrospective data collection in Colombian patients with ovarian cancer

Description

Abstract Ovarian cancer is one of the leading causes of death from gynecologic cancer. In Colombia, as in the world, its diagnosis is made in late stages due to the absence of specific symptoms of this disease. Objective: The objective of the Ovarian Cancer Registry is (i) to collect clinical and histopathological data using a standardized protocol, (ii) to characterize these patients clinically and histopathological to optimize the diagnosis and treatment, to describe these clinical aspects, which will allow us to understand the clinical particularities of this disease better. Methods: The Ovarian Cancer Registry is designed as a retrospective for data collection on OVAR patients. All patients under medical care at the Hospital Universitario Mayor Méderi and who have arrived in three possible routes or scenarios: (i) outpatient care, (ii) assessment in emergency services and (iii) references to the oncology service. The OVAR will have information on patients who consulted the Major Hospital from the first of January 2021 with CIE10 C56X and C482. Ethics and dissemination: The University of Rosario Ethics Committee approved registry protocol V02 (08/feb/24) No. 2541-CV1830 (Bogotá, Colombia). Registry leaders acknowledge their ongoing ethical responsibilities for all research using this data. Conclusion: The data from the Ovarian Cancer Registry will be instrumental in establishing optimal management strategies for OC patients, laying the groundwork for future guideline recommendations, and shaping the direction of upcoming research on the Colombian population.

Steps to reproduce

The patients to be included in the registry must have the following requirements: (i) Colombian women of legal age, treated at the Hospital Universitario Mayor Méderi (Bogotá, Colombia). (ii) Patients diagnosed with OC, International Classification of Diseases (CIE10), C56X and C482, determined from January 1, 2021. Who has the marker CA125 and diagnostic confirmation by anatomopathological study (reported in clinical history or pathology laboratory). (iii) Patients who, due to their condition, are under management by the gynecologic-oncology service of Méderi. Note: The diagnosis doesn't need to be made intra-hospital, if it has the diagnostic information mentioned in point two of the case definition. Information collection and systematization procedures The gyneco-oncology staff will identify the cases and oversee entering the data of the detected patients into a list system previously established in the institution. This base will be refined to generate a list where only patients who meet the case definition will be present for their subsequent entry to the registry. The leading group of the registry will send the list of patients to the digitizer to review medical records. The data will be obtained exclusively from the following sources: the electronic medical record systems Servinte®, Xerox, and Annarlab. Figure 1 represents the process from the entry of patients into the registry to collecting all the proposed information. Study data were collected and managed using REDCap electronic data capture (EDC) tools hosted at Hospital Universitario Mayor Méderi. REDCap (Research Electronic Data Capture) (https://project-redcap.org/) (10,11) is a secure, web-based software platform designed to support data capture for research studies, providing 1) an intuitive interface for validated data capture; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for data integration and interoperability with external sources (Table 1).

Institutions

• Hospital Universitario Mayor

Categories

Funders

• Institutional funding

  Grant ID: A-021-2023

Licence