About this trial
The goal of this retrospective observational study is to evaluate the relationship between different dietary patterns (specifically low-carbohydrate diets) and the prognosis of patients with high-grade serous ovarian cancer (HGSOC) receiving first-line PARP inhibitor (PARPi) maintenance therapy. The main questions it aims to answer are:
* Is there an association between dietary patterns and patients' Progression-Free Survival (PFS)? * Is there an association between dietary patterns and Overall Survival (OS)? This is a multicenter, retrospective cohort study. Researchers will review electronic medical records from 14 tertiary hospitals in China to identify women who received first-line PARP inhibitor maintenance for advanced high-grade serous ovarian cancer between 2020 and 2025, and collect information on baseline characteristics, treatments and follow-up outcomes.
Researchers will compare patients with a "low-carbohydrate diet pattern" to those with a "regular/high-carbohydrate diet pattern" to see if there are differences in treatment outcomes and survival.
Participants will:
* Have their clinical, pathological, and treatment data collected from electronic medical records. * Complete a retrospective Food Frequency Questionnaire (FFQ) via phone or clinic visit to recall their dietary habits during the maintenance treatment period. * Optionally provide a blood sample for nutrition and metabolic analysis. (For participants at the main study center only) No experimental drugs or specific diets will be given in this study. All anti-cancer treatments are decided by the treating physicians as part of routine clinical care.
Eligibility criteria
Qualifiers
Female patients aged 18 to <75 years.
Histologically or cytologically diagnosed with primary high-grade serous ovarian cancer (HGSOC), fallopian tube cancer, or primary peritoneal cancer.
Received initial tumor cytoreductive surgery (Primary Debulking Surgery or Interval Debulking Surgery) and first-line platinum-based chemotherapy, achieving Complete Response (CR) or Partial Response (PR).
Received PARP inhibitors as maintenance therapy for the first time following the completion of first-line treatment.
Disqualifiers
Clinical diagnosis only, without pathological or cytological confirmation.
Non-high-grade serous histological subtypes (e.g., ovarian clear cell carcinoma, endometrioid carcinoma, mucinous carcinoma, low-grade serous carcinoma).
Secondary or metastatic ovarian cancer (malignancy originating from other organs).
Severe deficiency of key clinical or prognostic information that prevents assessment of the primary endpoint.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Locations
Sponsors and collaborators
Tongji Hospital
Lead sponsor
West China Second University Hospital
Collaborator
Peking University People's Hospital
Collaborator
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
Qilu Hospital of Shandong University
Collaborator
Shanghai First Maternity and Infant Hospital
Collaborator
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
The First Affiliated Hospital of Soochow University
Collaborator
Henan Provincial People's Hospital
Collaborator
The First Affiliated Hospital of Henan University of Science and Technology
Collaborator
Women's Hospital of Zhejiang University
Collaborator
Sun Yat-Sen University Cancer Center
Collaborator