A Multicenter, Retrospective Clinical Study Evaluating the Effect of Different Dietary Patterns on the Prognosis of Ovarian Cancer Patients During PARPi Maintenance Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
- •Complete clinical data available in the electronic medical records, including baseline characteristics, first-line treatment details, PARPi maintenance therapy information, and prognostic follow-up data.
- •The patient (or primary caregiver) has normal communication abilities, voluntarily agrees to participate, and is able to cooperate in completing the retrospective Food Frequency Questionnaire (FFQ).
排除标准
- •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.
- •Inability to accurately recall dietary information due to cognitive impairment, mental illness, or other reasons.
- •Presence of severe metabolic or digestive system diseases during PARPi maintenance therapy that required specific restricted diets (e.g., insulin-dependent diabetes, dialysis-dependent renal insufficiency, short bowel syndrome, active Crohn's disease).
- •Occurrence of significant physiological events during the study period that significantly altered dietary structure (e.g., major gastrointestinal surgery).
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From the initiation of PARPi maintenance therapy until disease progression or death, assessed up to approximately 60 months (5 years).
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.
次要结局
- Duration of PARP Inhibitor Maintenance Therapy(From initiation of PARP inhibitor maintenance therapy to permanent discontinuation or last recorded dose, up to 5 years.)
- Overall Survival (OS)(From the initiation of PARPi maintenance therapy until death, assessed up to approximately 60 months.)
- Rate of Treatment Discontinuation Due to Adverse Events(From the initiation of PARPi maintenance therapy to treatment discontinuation, assessed up to approximately 60 months.)