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

NCT ID: NCT06037213

Last Updated: 2023-09-14

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

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-23

Study Completion Date

2024-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yang Xiang, MD.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Peng Peng, MD.

Role: CONTACT

+86-13521361934

Facility Contacts

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Peng Peng, MD.

Role: primary

+86-13521361934

Other Identifiers

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PekingUMCH-PRO1

Identifier Type: -

Identifier Source: org_study_id

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