Ovarian CancerNCT07269574
Impact of Dietary Patterns on Prognosis of Ovarian Cancer Patients During PARPi Maintenance
An observational study of Ovarian Cancer and Fallopian Tube Cancers, run by Tongji Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancers, Primary Peritoneal Carcinoma
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 27 Nov 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Retrospective Clinical Study Evaluating the Effect of Different Dietary Patterns on the Prognosis of Ovarian Cancer Patients During PARPi Maintenance Therapy
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.
Read more
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.
- Conditions
- Ovarian Cancer, Fallopian Tube Cancers, Primary Peritoneal Carcinoma, High-grade Serous Ovarian Cancer
- Keywords
- Ovarian Cancer, High-Grade Serous Ovarian Cancer, PARP Inhibitor, Maintenance Therapy, Dietary Pattern, Low-Carbohydrate Diet
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the initiation of PARPi maintenance therapy until disease progression or death, assessed up to approximately 60 months (5 years).
Secondary outcomes (3)
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.
Measured: From the initiation of PARPi maintenance therapy until death, assessed up to approximately 60 months.
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.
Measured: 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.
Measured: From the initiation of PARPi maintenance therapy to treatment discontinuation, assessed up to approximately 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start27 Nov 2025 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- West China Second University Hospital, Peking University People's Hospital, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Affiliated Hospital of Qingdao University, Qilu Hospital of Shandong University, Shanghai First Maternity and Infant Hospital, First Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital of Soochow University, Henan Provincial People's Hospital, The First Affiliated Hospital of Henan University of Science and Technology, Women's Hospital School Of Medicine Zhejiang University, Sun Yat-Sen University Cancer Center
- Responsible party
- Principal investigator, Qinglei Gao, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269574
- Sponsor's protocol ID
- TJH-OVC-PARPi-DIET
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Retrospective Clinical Study Evaluating the Effect of Different Dietary Patterns on the Prognosis of Ovarian Cancer Patients During PARPi Maintenance Therapy
- ClinicalTrials.gov ID
- NCT07269574
- Acronym / sponsor ID
- TJH-OVC-PARPi-DIET
- Conditions
- Ovarian Cancer, Fallopian Tube Cancers, Primary Peritoneal Carcinoma, High-grade Serous Ovarian Cancer
- Keywords
- Ovarian Cancer, High-Grade Serous Ovarian Cancer, PARP Inhibitor, Maintenance Therapy, Dietary Pattern, Low-Carbohydrate Diet
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- West China Second University Hospital, Peking University People's Hospital, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Affiliated Hospital of Qingdao University, Qilu Hospital of Shandong University, Shanghai First Maternity and Infant Hospital, First Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital of Soochow University, Henan Provincial People's Hospital, The First Affiliated Hospital of Henan University of Science and Technology, Women's Hospital School Of Medicine Zhejiang University, Sun Yat-Sen University Cancer Center
- Study start
- 27 Nov 2025 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-Free Survival (PFS)
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.
3 secondary outcomes
Overall Survival (OS)
Time frame: From the initiation of PARPi maintenance therapy until death, assessed up to approximately 60 months.
Duration of PARP Inhibitor Maintenance Therapy
Time frame: 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
Time frame: From the initiation of PARPi maintenance therapy to treatment discontinuation, assessed up to approximately 60 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Fallopian Tube Cancers, run by Tongji Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qinglei Gao, PhD. (+86-27-83662681, qingleigao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From the initiation of PARPi maintenance therapy until disease progression or death, assessed up to approximately 60 months (5 years).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.