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.
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.
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.
The study population consists of women with primary high-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who were treated at 14 tertiary hospitals in China. Eligible patients underwent primary or interval debulking surgery followed by first-line platinum-based chemotherapy, achieved complete or partial response, and then received a PARP inhibitor as first-line maintenance therapy between 2020 and 2025. Participants are identified from hospital electronic medical records, and those who can be contacted and are willing to participate will complete a retrospective food frequency questionnaire about their usual diet during PARP inhibitor maintenance.
Cohort
Retrospective
Not listed
Progression-Free Survival (PFS)
PFS is defined as the duration from the start date of PARP inhibitor (PARPi) maintenance therapy to the date of the first documented disease progression or death from any cause, whichever occurs first. Disease progression is assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for radiologic progression or Gynecologic Cancer InterGroup (GCIG) criteria for CA-125 biochemical progression.
Overall Survival (OS)
OS is defined as the time duration from the start date of PARPi maintenance therapy to the date of death from any cause. For participants who are still alive at the time of data analysis, survival time will be censored at the date of last contact/follow-up.
Duration of PARP Inhibitor Maintenance Therapy
Duration of PARP inhibitor (PARPi) maintenance therapy is defined as the time from the date of initiation of PARPi maintenance to the date of permanent discontinuation of PARPi for any reason (including disease progression, adverse events, patient preference, financial reasons, or other clinical decisions). Participants who are still receiving PARPi at the time of analysis will be censored at the date of the last recorded dose. This measure reflects treatment adherence to PARPi maintenance in routine clinical practice.
Rate of Treatment Discontinuation Due to Adverse Events
The percentage of participants who permanently discontinue PARP inhibitor maintenance therapy specifically due to drug-related adverse events or toxicity.
Click on the lead sponsor to view all of their trials.
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
This trial is not recruiting at the moment. You can still explore other options:
