Last updated: 03/05/2025 08:00:10
Endometrial cancer: Treatment patterns and clinical outcomes in Alberta, Canada
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Understanding treatment patterns and clinical outcomes in endometrial cancer in Alberta, Canada
Trial description: This is a longitudinal retrospective non-interventional observational cohort study, conducted to describe the clinical characteristics, health care resource utilization, treatment patterns, and clinical outcomes of endometrial cancer (EC) participants in Alberta, Canada. Females with a confirmed diagnosis of advanced or recurrent EC between 01-Jan-2010 and 31-Dec-2018 will be analyzed.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants newly diagnosed with endometrial cancer (EC) per year
Timeframe: Up to 9 years
Total number of participants diagnosed with EC over the study period
Timeframe: Up to 9 years
Demographic and clinical characteristics of participants with advanced (stage IIB/IIIC or IV) or recurrent EC
Timeframe: Up to 9 years
Treatment sequence patterns in advanced (stage IIB/IIIC or IV) or recurrent EC
Timeframe: Up to 10 years
Frequency and duration of each line of therapy
Timeframe: Up to 10 years
Overall survival (OS)
Timeframe: Up to 10 years
Time to Initial Treatment
Timeframe: Up to 10 years
Time to next treatment (TTNT)
Timeframe: Up to 10 years
Participants healthcare resource utilization
Timeframe: Up to 10 years
Treatment patterns among EC participants from subset chart abstractions
Timeframe: Up to 3 years
OS as per subset chart abstraction
Timeframe: Up to 3 years
TTNT as per subset chart abstraction
Timeframe: Up to 3 years
Number of participants with positive or negative Microsatellite instability (MSI)/Deoxyribonucleic acid (DNA) mis-match repair (dMMR) status from subset chart abstractions
Timeframe: Up to 3 years
Number of participants with EC Type (I and II) from subset chart abstractions
Timeframe: Up to 3 years
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
800
Primary completion date:
2021-14-10
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Martins D, O'Sullivan DE, Boyne DJ, Cheung WY, Allonby O, Habash M, Brenner DR, Riemer J, McGee J.Understanding Characteristics, Treatment Patterns, and Clinical Outcomes for Individuals with Advanced or Recurrent Endometrial Cancer in Alberta, Canada: A Retrospective, Population-based Cohort Study. Curr Oncol.2023;30(2):2277-2289
DOI: 10.3390/curroncol30020176
Medical condition
Neoplasms, Endometrial
Product
Not applicable
Collaborators
Oncology outcomes
Study date(s)
May 2021 to October 2021
Type
Observational
Phase
4
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- For objective 1, all adult females (18 plus [+] years) who were diagnosed with EC in Alberta, Canada between 2010 and 2018 will be included.
- For the remaining objectives, each potential participant must satisfy the following criteria to be eligible for data collection in this study: 1) Females aged 18 or older. 2) Confirmed diagnosis of advanced and/or recurrent EC in Alberta, Canada between 2010 and 2018. Advanced EC will be defined as de novo stage IIB/IIIC and IV EC, identified using registry data. Recurrent EC will be defined as de novo stage I, II, IIA EC patients who experience disease recurrence. Recurrence will be based on a claims algorithm that captures receipt of treatment following treatment for the initial diagnosis of early stage disease, or death from cancer.
- For objective 1, there are no additional exclusion criteria.
- For the remaining objectives, individuals who present with stage I, II, or IIIA endometrial cancer will be excluded if there was no evidence of a recurrence based on the administrative claims data algorithm. In addition, individuals who present with a uterine sarcoma will be excluded.
Inclusion and exclusion criteria
Inclusion criteria:
- For objective 1, all adult females (18 plus [+] years) who were diagnosed with EC in Alberta, Canada between 2010 and 2018 will be included.
- For the remaining objectives, each potential participant must satisfy the following criteria to be eligible for data collection in this study: 1) Females aged 18 or older. 2) Confirmed diagnosis of advanced and/or recurrent EC in Alberta, Canada between 2010 and 2018. Advanced EC will be defined as de novo stage IIB/IIIC and IV EC, identified using registry data. Recurrent EC will be defined as de novo stage I, II, IIA EC patients who experience disease recurrence. Recurrence will be based on a claims algorithm that captures receipt of treatment following treatment for the initial diagnosis of early stage disease, or death from cancer.
Exclusion criteria:
- For objective 1, there are no additional exclusion criteria.
- For the remaining objectives, individuals who present with stage I, II, or IIIA endometrial cancer will be excluded if there was no evidence of a recurrence based on the administrative claims data algorithm. In addition, individuals who present with a uterine sarcoma will be excluded.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2021-14-10
Actual study completion date
2021-14-10
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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