Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04460768




Registration number
NCT04460768
Ethics application status
Date submitted
3/07/2020
Date registered
8/07/2020
Date last updated
27/09/2021

Titles & IDs
Public title
An INternational Frontline Ovarian Cancer Real World Management Study
Scientific title
A Multicountry, Multicenter, Retrospective Study Evaluating the Patient Characteristics, Disease Burden, Treatment Patterns, and Patient Journey of Advanced Epithelial Ovarian Cancer Patients: A Korean, Taiwanese, and Australian Secondary Database Study
Secondary ID [1] 0 0
D0817R00028
Universal Trial Number (UTN)
Trial acronym
INFORM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival
Timepoint [1] 0 0
Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018
Secondary outcome [1] 0 0
Platinum free interval
Timepoint [1] 0 0
Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018
Secondary outcome [2] 0 0
Time to progression
Timepoint [2] 0 0
Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018
Secondary outcome [3] 0 0
Duration of treatment
Timepoint [3] 0 0
Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018
Secondary outcome [4] 0 0
Time to first subsequent treatment
Timepoint [4] 0 0
Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018
Secondary outcome [5] 0 0
Overall survival
Timepoint [5] 0 0
Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018

Eligibility
Key inclusion criteria
* 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
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/11/2020
Sample size
Target
Accrual to date
Final
989
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
D0817R00028 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Korea, Republic of
State/province [1] 0 0
Seoul
Country [2] 0 0
Taiwan
State/province [2] 0 0
New Taipei City
Country [3] 0 0
Taiwan
State/province [3] 0 0
Taipei City

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT04460768
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04460768