Efficacy and Adverse Effects of Niraparib in Ovarian Cancer.

NCT05583799 | Unknown

• 1 other identifier: XJTU1AF2022LSK-354
• Study Type: observational
• Target: 222
• Locations: 0 countries
• Sites: N/A

Brief Summary

Ovarian cancer is the second fatal gynecological cancer. More than 70% of ovarian cancer patients are diagnosed as advanced. Niraparib was approved by the National Medical Products Administration on December 27, 2019. It can be used as a maintenance treatment for adult patients with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer after platinum-containing chemotherapy has achieved complete or partial remission. On September 10, 2020, niraparib became a poly ADP-ribose polymerase inhibitor approved in China and globally, which can be used as a single agent for the maintenance treatment of first-line and recurrent ovarian cancer regardless of the patient's biomarker status. On December 28, 2020, niraparib has been included in the new version of the medical insurance catalog. At present, most studies based on niraparib are randomized controlled trials (RCTs). RCTs often have strict inclusion and exclusion criteria and they are implemented in a highly standardized environment. Its internal validity is high, but the research results may not be able to be extrapolated to practice. This study is a prospective real-world study. In this study, based on the modified Response Evaluation Criteria in Solid Tumors v.1.1 criteria, we evaluated the use of niraparib in patients with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in the progression-free survival, overall survival, and objective control rate, etc. The safety and tolerability of niraparib and the impact on the quality of life of patients are evaluated. 10ml blood samples of enrolled patients are collected at baseline and study endpoints respectively (only for enrolled patients who agree to blood sampling) for exploratory biological marker research and exploratory pharmacogenetic analysis. Finally, the results will as a supplement to the conclusions of randomized controlled trials to provide better guidance for patients.

Conditions

Ovarian Cancer

Keywords

niraparib; efficacy and adverse effects; real word; prospective; product registration study

Outcome Measures

Primary Outcomes (2)

• Progression-free survival

  Progression-free survival is defined as the time from the first day of niraparib administration to disease progression (defined as objective radiological disease progression using modified Response Evaluation Criteria in Solid Tumors v.1.1 criteria or clinical progression) or death.

  24 months

• Incidence of Adverse Events

  Adverse events classified according to Common Terminology Criteria for Adverse Events version 5.0.

  24 months

Secondary Outcomes (3)

• Overall survival

  60 months

• Objective response rate

  24 months

• Health-related quality of life (HRQoL).

  24 months

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 primary ovarian cancer, fallopian tube cancer, or peritoneal cancer confirmed by histology

You may qualify if:

• Patients with primary ovarian cancer, fallopian tube cancer, or peritoneal cancer confirmed by histology.
• Patients who are taking niraparib.
• Age greater than or equal to 18 years old.
• Patients should voluntarily participate in the trial and provide signed informed consent.

You may not qualify if:

• Patients who are not currently taking niraparib treatment.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Biospecimen

Retention: SAMPLES WITH DNA

10ml blood samples of enrolled patients are collected at baseline and study endpoints respectively (only for enrolled patients who agree to blood sampling) for exploratory biological marker research and exploratory pharmacogenetic analysis. All collected specimens will be kept in the first affiliated Hospital of Xi'an Jiaotong University.

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; 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

• Qiling Li, Ph.D

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiling Li, Dr.

CONTACT

02985323849; liqiling@mail.xjtu.edu.cn

Xue Zhou

CONTACT

15332603819; 804185744@qq.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: October 18, 2022
• Study Start: October 15, 2022
• Primary Completion: May 31, 2025
• Study Completion: September 30, 2025
• Last Updated: October 18, 2022

Record last verified: 2022-09