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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04460768
Ethics application status
Date submitted
3/07/2020
Date registered
8/07/2020
Date last updated
8/04/2021

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 - 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.
Timepoint [1] 0 0
Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018
Secondary outcome [1] 0 0
Platinum free interval - The number of months elapsed from the last day of platinum chemotherapy for first line of treatment to the date of diagnosis of disease recurrence or date of last follow-up if the patient did not recur during the study period
Timepoint [1] 0 0
Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018
Secondary outcome [2] 0 0
Time to progression - The length of time from the date of cancer diagnosis or the start of anti-cancer treatment until the cancer starts to get worse or spread to other parts of the body.
Timepoint [2] 0 0
Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018
Secondary outcome [3] 0 0
Duration of treatment - The length of time from the start of anti-cancer treatment to end of anti-cancer 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 - The length of time from the date of cancer diagnosis to the start of cancer treatment after cancer progression
Timepoint [4] 0 0
Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018
Secondary outcome [5] 0 0
Overall survival - Duration from the index date to the date of death (if available)
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/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
Other publications