PARPi and Ovarian Cancer Survival

NCT ID: NCT06838429

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-31

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum PARP Inhibitor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institute for Ovarian Cancer, Fudan University; Department of Gynecologic Oncology, Cancer Center, Fudan University Zhongshan Hospital, Shanghai, China

UNKNOWN

Sponsor Role collaborator

Department of Gynecologic Oncology, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China

UNKNOWN

Sponsor Role collaborator

Department of Gynecologic Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Sun Yat-sen University

UNKNOWN

Sponsor Role collaborator

Department of Gynecologic Oncology, Fudan University Cancer Hospital, Shanghai, China

UNKNOWN

Sponsor Role collaborator

Shanghai Gynecologic Oncology Group

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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PARPi_OC

Identifier Type: -

Identifier Source: org_study_id

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