NCT07269574Not yet recruiting
Impact of Dietary Patterns on Prognosis of Ovarian Cancer Patients During PARPi Maintenance
A Multicenter, Retrospective Clinical Study Evaluating the Effect of Different Dietary Patterns on the Prognosis of Ovarian Cancer Patients During PARPi Maintenance Therapy
Source: ClinicalTrials.gov · Last updated 8 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 26 Nov 2025
- Start date
- Nov 2025
- Primary completion date
- Nov 2026
- Lead sponsor
- Tongji Hospital
- Diseases
- Ovarian cancer
- NCT number
- NCT07269574
What you commit to
- Study type: Observational
- Planned participants: 600
- From Nov 2025 to the primary completion date, Nov 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Occurrence of significant physiological events during the study period that significantly altered dietary structure (e.g., major gastrointestinal surgery).
Other illness
- Secondary or metastatic ovarian cancer (malignancy originating from other organs).
- 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).
Other
- 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).
- Severe deficiency of key clinical or prognostic information that prevents assessment of the primary endpoint.
Who the study is looking for
- 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).
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.