Impact of Dietary Patterns on Prognosis of Ovarian Cancer Patients During PARPi Maintenance

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-75
SponsorTongji Hospital

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

600 Participants
are grouped into 2 trial groups

Locations

This trial has no 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