NCT04699006

Brief Summary

Ovarian cancer is the second fatal gynecological cancer. More than 70% of ovarian cancer patients are diagnosed as advanced. Olaparib is the first oral poly adenosine diphosphate-ribose polymerase inhibitor (PAPPi) approved by the U.S. Drug Administration (FDA) in December 2014. It can be used as a maintenance treatment for adult patients with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer after platinum-containing chemotherapy has achieved complete or partial remission. At present, most studies based on olaparib are randomized controlled trials (RCTs). Because 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 (RECIST 1.1), we evaluate the use of olaparib in patients with ovarian cancer, fallopian tube cancer, and primary peritoneal cancer in the progression-free survival (PFS), overall survival (OS), and objective control rate (ORR), etc. At the same time, the safety and tolerability of olaparib and the impact on the quality of life of patients are evaluated. Finally, we analyze the results as a supplement to the conclusions of randomized controlled trials to provide better guidance for patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
245

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

January 21, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

June 15, 2023

Status Verified

December 1, 2022

Enrollment Period

2.9 years

First QC Date

December 17, 2020

Last Update Submit

June 12, 2023

Conditions

Ovarian Cancer

Keywords

olaparibreal wordprospectiveefficacy and adverse effectsproduct registration study

Outcome Measures

Primary Outcomes (2)

  • Progression-free survival (PFS)

    PFS is defined as the time from the first day of olaparib administration to disease progression (defined as objective radiological disease progression using modified Recist version 1.1 or clinical progression) or death.

    24 months

  • Adverse event(AE)

    Adverse Event (AE) refers to all the adverse medical events that occur after the subject receives the experimental drug. It can be manifested as symptoms and signs, diseases or abnormal laboratory tests, but it may not be causally related to the experimental drug.

    24 months

Secondary Outcomes (3)

  • Overall survival (OS)

    60 months

  • Objective response rate (ORR)

    24 months

  • Health-related quality of life (HRQoL)

    24 months

Other Outcomes (5)

  • BRCA1/2 mutation status

    24 months

  • Platinum sensitivity status

    24 months

  • Histological classification

    24 months

  • +2 more other outcomes

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients are taking olaparib who suffer from 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 olaparib.
  • Patients should voluntarily participate in the trial and provide signed informed consent.

You may not qualify if:

  • \) Patients who are not currently taking olaparib treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

20ml blood samples and surgically removed histological samples of enrolled patients are collected (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 NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Qiling Li, MD,PhD

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2020

First Posted

January 7, 2021

Study Start

January 21, 2021

Primary Completion

January 1, 2024

Study Completion

January 1, 2026

Last Updated

June 15, 2023

Record last verified: 2022-12

Locations

CN(1)