Protocol of the SOCFC Project: a Longitudinal Cohort Study of Ovarian Cancer Patients, High-risk Populations, and Healthy Controls to Identify Factors and Biomarkers Associated with Disease Diagnosis and Prognosis

Background: Ovarian cancer (OC) poses a significant threat to women's health due to its insidious onset, tendency to metastasize, and high recurrence rate. These characteristics significantly impede early diagnosis and effective interventions. The current lack of effective screening and prognostic tools necessitates urgent solutions. The Shanghai Ovarian Cancer and Family Care Project (SOCFCP) is an ongoing cohort study aiming to address these challenges by identifying factors and biomarkers associated with OC onset, treatment, and prognosis. The ultimate goal is to develop predictive models and assessments crucial for diagnosing, treating, and prognosing the disease.

Methods: During the study period from 2023 to 2028, the SOCFCP aims to recruit over 2000 patients with ovarian lesions, 900 high-risk individuals, and 3000 healthy controls in Shanghai, China, with long-term follow-up. The study comprises three cohorts: (1) a bidirectional patients cohort, comprising those diagnosed with ovarian disease and treated at the department of gynecologic oncology at Shanghai first maternity and infant hospital since 2013; (2) a prospective high-risk cohort, consisting of family members of ovarian and/or breast cancer patients, or individuals with related gene mutations; and (3) a healthy control cohort, drawn from women undergoing health examination at hospitals or participating in community gynecologic cancer screenings. Participants will attend regular visits for questionnaire surveys, anthropometric measurements, and the collection of biological specimens, such as blood, fecal, and tissue samples. Collected data encompass baseline information, sociodemographic details, hospital admission records, and biological and clinical parameters, alongside treatment information. Primary outcomes for the patient cohort include mortality, tumor recurrence, major complications, and changes in health-related quality of life post-diagnosis. For the high-risk and healthy cohorts, ovary-related diseases will serve as the primary outcome. Various predictive models, such as multivariate logistic models, Cox regression, and linear mixed-effects regression models, will be employed to analyze various endpoints appropriately.

Discussion: This extensive cohort study integrates a diverse range of information, including lifestyle factors, environmental influences, genetic characteristics, and clinical features, alongside an extensive collection of biological samples. The resources generated by this project will provide valuable foundations for a comprehensively understanding of the etiology, treatment, and prognosis of OC. The SOCFCP is poised to foster cutting-edge multidisciplinary research on OC, spanning both fundamental and clinical studies.

Trial Registration: NCT06118307 in ClinicalTrials.gov. Registration Date: November 7, 2023.