A Real-World Patient-Reported Outcomes Study in Patients With Long-Term Use of Niraparib

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Ovarian Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06037213

PekingUMCH-PRO1

Details and patient eligibility

About

This prospective, non-interventional study is designed to evaluate the quality of life of Chinese ovarian cancer patients with long-term niraparib use in a real-world setting. Participants will complete questionnaires or accept telephone follow-up to provide information about their quality of life.

Full description

In this prospective, non-interventional study, patients with platinum-sensitive relapsed ovarian cancer who have received niraparib as maintenance therapy for more than two years will agree to be contacted by questionnaire or telephone three times. The interval will be 4-6 weeks. Information on quality of life will be collected and analysed.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Histologically confirmed platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer
• Maintenance treatment with niraparib for ≥2 years and continuing for the next 28 days
• No significant cognitive impairment
• Understand the trial procedure and be able to sign the informed consent form before any study-related procedures

Exclusion criteria

• Patients who are not suitable for participation in this study according to the investigator's evaluation
• Patients receiving antineoplastic drugs for other malignancies
• Patients who are unable to comply with the protocol procedures