Evaluating quality of life in ovarian cancer patients using niraparib
Non-interventional Study to Collect Real-world Patient-Reported Outcomes Data in Platinum-Sensitive Relapsed Ovarian Cancer Patients With Long-Term Use of Niraparib
This study is trying to see how taking the drug niraparib for more than two years affects the daily lives and well-being of Chinese patients with relapsed ovarian cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06037213 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the quality of life in Chinese patients with platinum-sensitive relapsed ovarian cancer who have been on niraparib maintenance therapy for over two years. Participants will provide feedback through questionnaires or telephone follow-ups at intervals of 4-6 weeks. The study focuses on gathering real-world patient-reported outcomes to better understand the impact of long-term niraparib use on daily living and overall well-being.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed platinum-sensitive recurrent ovarian cancer who have been on niraparib for at least two years.
Not a fit: Patients with significant cognitive impairment or those receiving treatment for other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effects of niraparib on quality of life for ovarian cancer patients.
How similar studies have performed: While this study focuses on a specific patient population and treatment, similar studies evaluating patient-reported outcomes in cancer therapies have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing, Beijing
- Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Yang Xiang, MD. — Peking Union Medical College Hospital
- Study coordinator: Peng Peng, MD.
- Email: pengp1999@163.com
- Phone: +86-13521361934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.