Real-world Study of Niraparib Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer

NCT04986371 | Unknown

• 1 other identifier: 21/251-2922
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open-label, single-arm, multi-center、non-interventional real-world study, which evaluate treatment pattern, safety and efficacy of Niraparib as first-line maintenance treatment for Chinese patient with newly diagnosed ovarian cancer , fallopian tube cancer, and primary peritoneal cancer in real world clinical practice.

Conditions

Epithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (4)

• Starting dose of Niraparib

  Record the starting dose of Niraparib in real clinical practice

  up to 3 years

• Percentage of patients who have taken dose adjustment and the reason of dose adjustment

  Record the percentage of patients who have taken dose adjustment and the reason of dose adjustment

  up to 3 years

• Percentage of patients who have taken dose discontinuation and the reason of dose discontinuation

  Record the percentage of patients who have taken dose discontinuation and the reason of dose discontinuation

  up to 3 years

• Concomitant treatments which patients take along with Niraparib

  Record the concomitant treatments (drugs, or other tumor treatments) which patients take along with Niraparib

  up to 3 years

Secondary Outcomes (6)

• Incidence of all AEs

  up to 3 years

• Progression-free survival (PFS)

  up to 3 years

• Time to First Subsequent Therapy (TFST)

  up to 3 years

• Chemotherapy-Free Interval (CFI)

  up to 3 years

• Overall Survival (OS)

  up to 3 years

Interventions

Niraparib DRUG

Usage following drug insert is recommended

Also known as: Zejula

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed ovarian cancer

You may qualify if:

• Women aged 18 years or older
• Histologically confirmed epithelial ovarian cancer, carcinoma of fallopian tube or primary peritoneal carcinoma
• Having received one line of platinum-based chemotherapy, and clinically CR or PR to this line of chemotherapy
• Understand the protocol, and Written informed consent before any study-related procedure

You may not qualify if:

• Participating in other clinical trials at the same time
• Having sever or uncontrolled diseases that will influence the study, according to the judgement of investigators
• Having other malignant tumors (other than breast cancer with BRCA mutation)
• Pregnancy or breast feeding, or planning a pregnancy during the study
• Unable to visit on time
• Patients who are allergic to the study drug or drug components

Sponsors & Collaborators

• Ling-Ying Wu: lead

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue, peripheral blood

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

niraparib

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 Officials

• Lingying Wu

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lingying Wu

CONTACT

010-87788996; wulingying@csco.org.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: UNKNOWN
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: August 2, 2021
• Study Start: August 10, 2021
• Primary Completion: August 31, 2022
• Study Completion: February 28, 2025
• Last Updated: August 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share