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Trial registered on ANZCTR
Registration number
ACTRN12624000396527
Ethics application status
Approved
Date submitted
12/01/2024
Date registered
3/04/2024
Date last updated
3/04/2024
Date data sharing statement initially provided
3/04/2024
Date results provided
3/04/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
The impact of COVID-19 on colorectal cancer in regional Northern Queensland and changes to treatment related to distance to care
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Scientific title
The impact of COVID-19 on colorectal cancer in regional Northern Queensland and changes to treatment related to distance to care
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Secondary ID [1]
311312
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n/a
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
colorectal cancer
332563
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COVID-19
332564
0
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Condition category
Condition code
Surgery
329263
329263
0
0
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Other surgery
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Infection
329758
329758
0
0
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Other infectious diseases
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Cancer
329759
329759
0
0
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Bowel - Back passage (rectum) or large bowel (colon)
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Respiratory
329760
329760
0
0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Patients being treated with colorectal cancer will be assessed during the COVID 19 pandemic to assess if there has been increased emergency presentations and other changes to their treatment profile
There will be no direct patient contact, a retrospective review of patient charts will be undertaken
Observation would be for that current time perioud between March 2019 - July 2022
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Intervention code [1]
327761
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Diagnosis / Prognosis
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Comparator / control treatment
Those patients treated during COVID will be compared to those treated prior to covid
March 2019-July 2019 (pre-COVID period) and March 2020-July 2022 (COVID period)
Data collection occurred between 17/8/22 after ethics approval and 31/1/2023 when data collection complete
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Control group
Historical
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Outcomes
Primary outcome [1]
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primary aim to review number of emergency presentations with more advanced disease in terms of colorectal cancer during the COVID 19 pandemic compared to the Pre-COVID time period.
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Assessment method [1]
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The number of emergency presentations will be compared between the 2 time periods prevoid-19 and during covid-19
March 2019-July 2019) vs
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Timepoint [1]
337084
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COVID March 2020-July 2022.
Pre covid
March 2019-July 2019) March 2020-July 2022
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Secondary outcome [1]
430610
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• Compare complication rates
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Assessment method [1]
430610
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Data will be provided by the Clinical information Service (CIS) in a spreadsheet and manually by reviewing patients medical records (ieMR and medical imaging and pathology .Data will be collected and compared between the two time periods
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Timepoint [1]
430610
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pre-covid March 2019-July 2019
during covid March 2020-July 2022
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Secondary outcome [2]
432259
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Assessing referral times during covid-19 and prior to the pandeminc lead to assess time between GP referral and definitive management of CRC
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Assessment method [2]
432259
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Data will be provided by the Clinical information Service (CIS) in a spreadsheet and manually by reviewing patients medical records (ieMR and medical imaging and pathology
Reviewing patient charts and assessing when the referral for symptoms was performed and assessing when patients had screening colonoscopy and ultimately the definitive management
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Timepoint [2]
432259
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March 2019-July 2019 (pre-COVID period) and March 2020-July 2022 (COVID period)
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Secondary outcome [3]
432260
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Distance to care that patients had to travel from home to the hospital being managed definitively in
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Assessment method [3]
432260
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distance to care
Distance will be calculated from the city they live to the TUH
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Timepoint [3]
432260
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March 2019-July 2022
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Secondary outcome [4]
432261
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Open or laparoscopic resection
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Assessment method [4]
432261
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Reviewing operation notes to assess if open or laparoscopic
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Timepoint [4]
432261
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March 2019 - July 2022
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Secondary outcome [5]
432262
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Stage of cancer at time of operation or diagnosis if already metastatic
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Assessment method [5]
432262
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Checking histology from the patient data or when first diagnosed with metastatic disease
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Timepoint [5]
432262
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March 2019 - July 2022
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Secondary outcome [6]
433334
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length of stay
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Assessment method [6]
433334
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time spent in hospital collated and dertermined from medical records
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Timepoint [6]
433334
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march 2019-july 2022
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Eligibility
Key inclusion criteria
Inclusion criteria: all patients that were diagnosed or treated for colorectal cancer during the time periods being analysed and definitively managed at the Townsville University Hospital
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria: patients treated for benign pathology and for non colonic/rectal adenocarcinoma i.e. anal scc
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Defined population
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Timing
Retrospective
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Statistical methods / analysis
All statistics were examined using SPSS statistics for Windows; SPSS Statistics for Windows, Version 27.0 Armonk, NY: IBM Corp. and RStudio Team (2015) version 0.99.486, Integrated Development for R. RStudio, Inc., Boston, MA. A p value of <0.05 was considered to be statistically significant; Pearons Chi Squared or Fishers Exact Test were used depending upon the sample size in each group. For assessment of continuous data Mann Whitney u was used, in this study this was the days to referral and being managed as well as the distance to care
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
17/08/2022
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Date of last participant enrolment
Anticipated
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Actual
31/01/2023
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Date of last data collection
Anticipated
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Actual
31/01/2023
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Sample size
Target
200
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Accrual to date
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Final
500
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
26011
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Townsville University Hospital - Douglas
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Recruitment postcode(s) [1]
41858
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4814 - Douglas
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Funding & Sponsors
Funding source category [1]
315566
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Self funded/Unfunded
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Name [1]
315566
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Address [1]
315566
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Country [1]
315566
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Primary sponsor type
Individual
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Name
Richard Maguire
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Address
48 121-125 Surf Parade Broadbeach
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Country
Australia
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Secondary sponsor category [1]
317657
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None
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Name [1]
317657
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Address [1]
317657
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48 121-125 Surf Parade Broadbeach
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Country [1]
317657
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
314465
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Townsville Hospital and Health Service Audit, Quality and Innovation Review (AQUIRE) Panel
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Ethics committee address [1]
314465
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100 Angus Smith Drive Douglas 4814 QLD
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Ethics committee country [1]
314465
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Australia
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Date submitted for ethics approval [1]
314465
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25/07/2022
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Approval date [1]
314465
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17/08/2022
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Ethics approval number [1]
314465
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THHSAQUIRE1492
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Summary
Brief summary
The COVID-19 pandemic has created challenges in the diagnosis and management of colorectal cancer (CRC). It was proposed in regional North Queensland the distance to services could further impact cancer outcomes, leading to delayed diagnosis. We compared the outcomes of patients prior and during the pandemic; with a focus on whether patients were presenting in the emergency setting with more advanced disease (i.e.T4 tumours, locally advanced cancers or stage III/IV CRC). The distance to treatment was also analysed to see if any impact occurred to the management of patients with colorectal cancer.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Richard Maguire
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Address
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100 Angus Smith Drive, Douglas 4215 QLD Townsville University Hospital
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Country
131674
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Australia
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Phone
131674
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+61 0438634824
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Fax
131674
0
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Email
131674
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[email protected]
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Contact person for public queries
Name
131675
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Richard Maguire
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Address
131675
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100 Angus Smith Drive, Douglas 4215 QLD Townsville University Hospital
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Country
131675
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Australia
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Phone
131675
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+61 0438634824
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Fax
131675
0
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Email
131675
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[email protected]
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Contact person for scientific queries
Name
131676
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Richard Maguire
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Address
131676
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100 Angus Smith Drive, Douglas 4215 QLD Townsville University Hospital
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Country
131676
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Australia
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Phone
131676
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+61 0438634824
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Fax
131676
0
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Email
131676
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
De-identified data for the purpose of research not to be distributed outside the health service
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
21370
Study protocol
[email protected]
see upload
387154-(Uploaded-12-01-2024-12-16-52)-Study-related document.docx
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF