NCT07269574Toborzás még nem indult
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 8.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 600 (tervezett)
- Első benyújtás
- 2025. nov. 26.
- Kezdés
- 2025. nov. 27.
- Elsődleges befejezés
- 2026. nov. 30.
- Fő szponzor
- Tongji Hospital
- Betegségek
- Petefészekrák
- NCT-szám
- NCT07269574
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 600
- 2025. nov. 27. és az elsődleges befejezés (2026. nov. 30.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Occurrence of significant physiological events during the study period that significantly altered dietary structure (e.g., major gastrointestinal surgery).
Más betegség
- 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).
Egyéb
- 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.
Kiket keres a vizsgálat
- 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).
Életkor a regiszterben: 18 év – 75 év · Nem: csak nők · Egészséges önkénteseket nem fogad
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