PARPi and Ovarian Cancer Survival

NCT06838429 | Not Yet Recruiting

• 1 other identifier: PARPi_OC
• Study Type: observational
• Target: 6,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum; PARP Inhibitor

Outcome Measures

Primary Outcomes (1)

• Overall Mortality

  Mortality of any cause

  11 years

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Gynecologic Oncology Group: lead
• Institute for Ovarian Cancer, Fudan University; Department of Gynecologic Oncology, Cancer Center, Fudan University Zhongshan Hospital, Shanghai, China: collaborator
• Department of Gynecologic Oncology, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China: collaborator
• Department of Gynecologic Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Sun Yat-sen University: collaborator
• Department of Gynecologic Oncology, Fudan University Cancer Hospital, Shanghai, China: collaborator

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 20, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 20, 2025

Record last verified: 2025-02