Epithelial Ovarian Cancer, Fallopian Tube or PeritoneumNCT06838429
PARPi and Ovarian Cancer Survival
An observational study of Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum and PARP Inhibitor, run by Shanghai Gynecologic Oncology Group.
Trial summary
With the widespread use of PARP inhibitors (PARPi) as maintenance therapy in ovarian cancer, there is still a lack of real-world data from large samples regarding their impact on survival outcomes in advanced and recurrent ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum, PARP Inhibitor
- Type of treatment
- Injection or infusion
- How many people
- 6,000 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Mar 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were newly diagnosed with stage IIIC or IV primary epithelial ovarian cancer or had platinum-sensitive first relapsed ovarian cancer between December 2013 and December 2024.
Who may be able to join
- Group 1:
- Patients newly diagnosed with stage IIIC or IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer between December 2013 and December 2024.
- Complete data on first-line treatment and maintenance therapy.
- Availability of follow-up data.
- Group 2:
- Patients with platinum-sensitive first recurrence of any stage of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, diagnosed between December 2013 and December 2024.
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- Disease progression occurring at least 6 months after the completion of the last platinum-based chemotherapy regimen.
- Complete data on second-line treatment and maintenance therapy.
- Availability of follow-up data.
Who cannot join
- Group 1:
- Non-epithelial tumors, borderline tumors, clear cell carcinoma, mucinous carcinoma.
- Missing first-line or follow-up data.
- Group 2:
- Non-epithelial tumors, borderline tumors, clear cell carcinoma, mucinous carcinoma.
- Patients with second relapse.
- Platinum-resistant patients, such as those who had disease progression during chemotherapy or within 6 months after platinum-based chemotherapy.
- Missing second-line or follow-up data.
About this study
Official title: Effect of PARP Inhibitors Maintenance Therapy on the Survival Rate of Advanced or Relapsed Epitherlial Ovarian Cancer: an Observational Cohort Study
With the widespread use of PARP inhibitors (PARPi) as maintenance therapy in ovarian cancer, there is still a lack of real-world data from large samples regarding their impact on survival outcomes in advanced and recurrent ovarian cancer. This study aims to conduct a pragmatic cohort study to evaluate the impact of first-line and second-line maintenance treatment with PARPi on survival rates in patients with advanced and recurrent ovarian cancer. The genetic status, different PARPi drugs, and the use of anti-angiogenic inhibitor maintenance therapy or not is used as confounding factors.
- Medical subject headings
- Carcinoma, Ovarian Epithelial
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 |
|---|---|---|
| Patients with newly diagnosed advanced epithelial ovarian cancer | Patients who were newly diagnosed with stage IIIC or IV primary epithelial ovarian cancer between December 2013 and December 2024. | |
| Patients with platinum-sensitive first relapsed epithelial ovarian cancer | Patients with platinum-sensitive first relapsed ovarian cancer who were diagnosed between December 2013 and December 2024 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Mortality
Mortality of any cause
Measured: 11 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study startMar 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian Cancer, Fallopian Tube or PeritoneumStudies of the same condition, open and under way.
- 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
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Gynecologic Oncology Group
- Sponsor type
- Other government
- Collaborators
- Fudan University, Department of Gynecologic Oncology, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China, Department of Gynecologic Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Sun Yat-sen University, Department of Gynecologic Oncology, Fudan University Cancer Hospital, Shanghai, China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838429
- Sponsor's protocol ID
- PARPi_OC
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of PARP Inhibitors Maintenance Therapy on the Survival Rate of Advanced or Relapsed Epitherlial Ovarian Cancer: an Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06838429
- Acronym / sponsor ID
- PARPi_OC
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Shanghai Gynecologic Oncology GroupOther government
- Collaborators
- Fudan University, Department of Gynecologic Oncology, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China, Department of Gynecologic Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Sun Yat-sen University, Department of Gynecologic Oncology, Fudan University Cancer Hospital, Shanghai, China
- Study start
- Mar 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 20 Feb 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.
With the widespread use of PARP inhibitors (PARPi) as maintenance therapy in ovarian cancer, there is still a lack of real-world data from large samples regarding their impact on survival outcomes in advanced and recurrent ovarian cancer. This study aims to conduct a pragmatic cohort study to evaluate the impact of first-line and second-line maintenance treatment with PARPi on survival rates in patients with advanced and recurrent ovarian cancer. The genetic status, different PARPi drugs, and the use of anti-angiogenic inhibitor maintenance therapy or not is used as confounding factors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with newly diagnosed advanced epithelial ovarian cancer | – | –Patients who were newly diagnosed with stage IIIC or IV primary epithelial ovarian cancer between December 2013 and December 2024. |
| Patients with platinum-sensitive first relapsed epithelial ovarian cancer | – | –Patients with platinum-sensitive first relapsed ovarian cancer who were diagnosed between December 2013 and December 2024 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were newly diagnosed with stage IIIC or IV primary epithelial ovarian cancer or had platinum-sensitive first relapsed ovarian cancer between December 2013 and December 2024.
Key inclusion criteria (9 listed)
- Patients newly diagnosed with stage IIIC or IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer between December 2013 and December 2024.
- Complete data on first-line treatment and maintenance therapy.
- Availability of follow-up data.
- Patients with platinum-sensitive first recurrence of any stage of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, diagnosed between December 2013 and December 2024.
- Disease progression occurring at least 6 months after the completion of the last platinum-based chemotherapy regimen.
Key exclusion criteria (8 listed)
- Non-epithelial tumors, borderline tumors, clear cell carcinoma, mucinous carcinoma.
- Missing first-line or follow-up data.
- Non-epithelial tumors, borderline tumors, clear cell carcinoma, mucinous carcinoma.
- Patients with second relapse.
- Platinum-resistant patients, such as those who had disease progression during chemotherapy or within 6 months after platinum-based chemotherapy.
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
Overall Mortality
Time frame: 11 years
Mortality of any cause
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 20 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum and PARP Inhibitor, run by Shanghai Gynecologic Oncology Group.
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 9 inclusion and 8 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 20 Feb 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Mortality (time frame: 11 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 20 Feb 2025.