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Not yet recruitingNCT06838429Updated Feb 20, 2025

PARPi and Ovarian Cancer Survival

An observational study in Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum and PARP Inhibitor, sponsored by Shanghai Gynecologic Oncology Group. Not yet recruiting. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-20.

Sponsored by Shanghai Gynecologic Oncology Group · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
6,000
Ages
18 Years to 80 Years
Sex
Female
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Study 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. 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.

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Conditions studied

  • Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum
  • PARP Inhibitor
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In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's planned enrollment of 6,000 is above the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Shanghai Gynecologic Oncology Group is the lead sponsor of 15 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

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.
  • 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.

Exclusion criteria

Exclusion Criteria:

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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
6,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. Overall Mortality

    Mortality of any cause

    Time frame: 11 years

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06838429
Lead sponsor
Shanghai Gynecologic Oncology Group
Collaborators
Institute for Ovarian Cancer, Fudan University; Department of Gynecologic Oncology, Cancer Center, Fudan University Zhongshan Hospital, Shanghai, China, 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
First posted
Feb 20, 2025
Start date
Mar 2025 (estimated)
Primary completion
Mar 2026 (estimated)
Completion
Mar 2026 (estimated)
Last update
Feb 20, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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