A Real-world Study of Mirvetuximab Soravtansine (MIRV) in Ovarian Cancer Patients of Expression of Folate Receptor α(FRα)
NCT07690332
Adnexal Diseases, Endocrine Gland Neoplasms
View Trial DetailsNCT Number: NCT07269574
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.
Trial opening soon.
Get Notified18 year–75 year
Female
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: From the initiation of PARPi maintenance therapy until death, assessed up to approximately 60 months.
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.
Time frame: From initiation of PARP inhibitor maintenance therapy to permanent discontinuation or last recorded dose, up to 5 years.
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.
Time frame: From the initiation of PARPi maintenance therapy to treatment discontinuation, assessed up to approximately 60 months.
The percentage of participants who permanently discontinue PARP inhibitor maintenance therapy specifically due to drug-related adverse events or toxicity.
Contact information is provided by the study sponsor or research team.
Tongji Hospital
Other
A Multicenter, Retrospective Clinical Study Evaluating the Effect of Different Dietary Patterns on the Prognosis of Ovarian Cancer Patients During PARPi Maintenance Therapy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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