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| Name | Class |
|---|---|
| West China Second University Hospital | OTHER |
| Peking University People's Hospital | OTHER |
| Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center | OTHER |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-Carbohydrate Diet Pattern | Patients with high-grade serous ovarian cancer receiving first-line PARP inhibitor maintenance therapy whose usual dietary carbohydrate intake accounts for a lower proportion of total energy. The primary definition of this group will be patients with a percentage of total energy from carbohydrates below the cohort-specific median, as estimated from the retrospective food frequency questionnaire (FFQ). Alternative cut-offs based on published literature and dietary guidelines will be explored in sensitivity analyses. | ||
| Regular/High-Carbohydrate Diet Pattern | Patients with high-grade serous ovarian cancer receiving first-line PARP inhibitor maintenance therapy whose usual dietary carbohydrate intake accounts for a regular or higher proportion of total energy. The primary definition of this group will be patients with a percentage of total energy from carbohydrates at or above the cohort-specific median, as estimated from the retrospective food frequency questionnaire (FFQ). Alternative cut-offs based on published literature and dietary guidelines will be explored in sensitivity analyses. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the initiation of PARPi maintenance therapy until disease progression or death, assessed up to approximately 60 months (5 years). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the initiation of PARPi maintenance therapy until death, assessed up to approximately 60 months. |
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Inclusion Criteria:
Exclusion Criteria:
This study includes only women with ovarian, fallopian tube, or primary peritoneal cancer. These cancers arise in female reproductive organs, so only female patients who have been diagnosed with these conditions and received PARP inhibitor maintenance therapy are eligible for this study.
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qinglei Gao, PhD. | Contact | +86-27-83662681 | qingleigao@hotmail.com |
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It is currently undecided whether individual participant data (IPD) will be shared. The decision will be subject to compliance with the Data Security Law of the People's Republic of China and regulations on human genetic resources management. At this stage, the study protocol specifies that research results will be reported in aggregated summary forms to protect patient privacy. A final data sharing plan will be determined upon study completion in accordance with applicable laws and institutional policies.
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| OTHER |
| The Affiliated Hospital of Qingdao University | OTHER |
| Qilu Hospital of Shandong University | OTHER |
| Shanghai First Maternity and Infant Hospital | OTHER |
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| The First Affiliated Hospital of Soochow University | OTHER |
| Henan Provincial People's Hospital | OTHER |
| The First Affiliated Hospital of Henan University of Science and Technology | OTHER |
| Women's Hospital of Zhejiang University | UNKNOWN |
| Sun Yat-Sen University Cancer Center | OTHER |
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Venous blood samples (approximately 5 mL) will be collected from consenting participants at the main study center (Tongji Hospital). Samples will be processed into serum/plasma and stored at -80°C for at least 5 years. These biospecimens will be used for analyzing nutritional and metabolic indicators (e.g., albumin, lipids) and conducting exploratory omics research (including metabolomics, proteomics, and/or transcriptomics) to investigate the association between metabolic profiles and PARPi maintenance therapy outcomes.
| 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. | From initiation of PARP inhibitor maintenance therapy to permanent discontinuation or last recorded dose, up to 5 years. |
| 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. | From the initiation of PARPi maintenance therapy to treatment discontinuation, assessed up to approximately 60 months. |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |