NCT04460768

Brief Summary

The current study aims to analyze the existing secondary databases from Korea (Sungkyunkwan University, Samsung Medical Center, Seoul), Taiwan (National Taiwan University, Chang-Gung Medical Foundation Linkou Branch and Mackay Memorial Hospital), and Australia (Australian Ovarian Cancer Study \[AOCS\]) to leverage the already available data in the real-world setting to review the current standard of care in advanced epithelial ovarian cancer cases. The collected data will help provide the required information for assessing the unmet treatment needs in this patient group. The data will also provide the needed information to support any reimbursement activity needed for future novel therapies in this patient group

Trial Health

90
On Track

Trial Health Score

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

Enrollment
989

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
3 countries

4 active sites

Status
completed

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

Study Start

First participant enrolled

June 27, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2020

Completed
Last Updated

September 27, 2021

Status Verified

September 1, 2021

Enrollment Period

5 months

First QC Date

July 3, 2020

Last Update Submit

September 22, 2021

Conditions

Ovarian Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    In first line setting - length of time from diagnosis to first progression, death, or last follow-up. In second line setting, length of time from start of second line therapy until patient has disease progression, death, or last follow-up.

    Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018

Secondary Outcomes (5)

  • Platinum free interval

    Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018

  • Time to progression

    Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018

  • Duration of treatment

    Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018

  • Time to first subsequent treatment

    Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018

  • Overall survival

    Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018

Eligibility Criteria

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

This is a non-interventional study that involves retrospective collection of data from medical records of all patients who have been newly diagnosed with advanced-stage epithelial ovarian cancer (high grade serous type epithelial ovarian cancer for Taiwan) between the period Jan 2014-Dec 2018.

You may qualify if:

  • Female subjects above the age of 18
  • Patients with a confirmed diagnosis of advanced-stage (FIGO III/IV) epithelial (Serous \[high or low grade\], mucinous, endometrioid, clear cell, mixed, and others) ovarian cancer between the period Jan 2014 and Dec 2018, provided at least 12 months data is available (not mandatory to be ovarian cancer related) as a proxy of healthcare use prior to the diagnosis of advanced-stage epithelial ovarian cancer

You may not qualify if:

  • Patients being included in interventional clinical trials with PARPi for the treatment of advanced-stage high-grade epithelial ovarian cancer treatment during the study period
  • Patients with early stage disease (FIGO Stage I, IIA, IIB, or IIC)
  • Other malignancies within the past five years, except adequately treated non-melanoma skin cancer; curatively treated in situ cancer of the cervix; ductal carcinoma in situ; stage 1, grade 1 endometrial carcinoma; or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥5 years. Patients with a history of localized breast cancer may have been eligible, provided they completed their adjuvant chemotherapy more than three years prior to registration, and remained free of recurrent or metastatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

Melbourne, Victoria, D0817R00028, Australia

Location

Research Site

Seoul, D0817R00028, South Korea

Location

Research Site

New Taipei City, D0817R00028, Taiwan

Location

Research Site

Taipei, D0817R00028, Taiwan

Location

Related Links

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 Design

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

Study Record Dates

First Submitted

July 3, 2020

First Posted

July 8, 2020

Study Start

June 27, 2020

Primary Completion

November 10, 2020

Study Completion

November 10, 2020

Last Updated

September 27, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

No IPD will be shared.

Locations

AU(1)TW(2)KR(1)