Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001283268
Ethics application status
Approved
Date submitted
11/07/2018
Date registered
30/07/2018
Date last updated
30/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Study of Colorectal Cancer in Counties Manukau District Health Board.
Scientific title
A Prospective Observational Study of Colorectal Cancer in Counties Manukau District Health Board.
Secondary ID [1] 295622 0
None
Universal Trial Number (UTN)
U1111-1217-1457
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 308790 0
Condition category
Condition code
Cancer 307725 307725 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Aim/Methods:
To create a comprehensive, prospective database of all colorectal cancers diagnosed and treated in the Counties Manukau District Health Board (CMDHB).

Alerts of a diagnosis will be made via pathology, after histology is confirmatory for CRC.

Procedure: Epidemiological and follow-up data will be collected, and notes and patients reviewed as to risk factors, both traditional and modifiable, presentation and follow-up treatment and outcomes over 1 year.

Intervention code [1] 301833 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306708 0
To identify trends in symptoms, signs and risk factors of patients newly diagnosed with CRC.

Primary aim:
-Identifying number of patients presenting with certain symptoms/signs:
1) Iron deficiency anaemia (serum assay from medical records).
Timepoint [1] 306708 0
At time of referral
Primary outcome [2] 306883 0
-Identifying number of patients presenting with certain symptoms/signs:
2) Change in bowel habit (medical records from clinician involved in the patients care).
Timepoint [2] 306883 0
At time of referral
Primary outcome [3] 306884 0
-Identifying number of patients presenting with certain symptoms/signs:
3) Palpable mass on abdominal or digital rectal examination
Timepoint [3] 306884 0
At time of referral
Secondary outcome [1] 349316 0
To indentify treatment patterns. Data will be collected from patient medical records - clinic letters and record of interactions (no additional interactions with the patients).
Timepoint [1] 349316 0
Immediately following treatment
Secondary outcome [2] 349813 0
This is a composite outcome:
Treatments/Outcomes of patients newly diagnosed with CRC:

Date of referral to colonoscopy Date of diagnosis Method of initial Diagnosis (CT/CTC/Colonoscopy) Site of Cancer Synchronus tumour Y/N Stage at diagnosis (localised/regional/distant) Tumour pathology Treatment: Surgery Y/N Type of surgical resection Chemotherapy Y/N Radiotherapy Y/N

Data will be collected from medical records only.
Timepoint [2] 349813 0
6-12 months post treatment
Secondary outcome [3] 350021 0
This is a composite outcome:

Previous colonoscopy Y/N) Date of previous colonocopy Findings at previouscolonoscopy Family Hx 1st degree (<55) ETOH excess Y/N Red meat diet Y/N Processed diet (Y/N) BMI Smoker (pack years) Physical inactivity Y/N Hx IBD UC/Crohn's Bowel Screening program Y/N Predominant symtoms Duration of symptoms prior to diagnosis Lone Fe def Vegetarian/pescitarian
Timepoint [3] 350021 0
At time of referral

Eligibility
Key inclusion criteria
Inclusion Criteria:
-All consecutive adult patients (>15 years old) with a confirmed histological diagnosis of CRC
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
-Patients without confirmed histological diagnosis

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Analysis plan – Data will be analysed with the consultant on a 6 monthly basis.

Descriptive statistics will be used only

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/01/2018
Date of last participant enrolment
Anticipated
28/05/2021
Actual
Date of last data collection
Anticipated
28/10/2021
Actual
Sample size
Target
500
Accrual to date
30
Final
Recruitment outside Australia
Country [1] 10639 0
New Zealand
State/province [1] 10639 0

Funding & Sponsors
Funding source category [1] 300104 0
Hospital
Name [1] 300104 0
Counties Manukau District Health Board
Country [1] 300104 0
New Zealand
Primary sponsor type
Hospital
Name
Counties Manukau District Health Board
Address
Counties Manukau District Health Board
C/O Middlemore Hospital
100 Hospital Rd, Otahuhu
Auckland 2025
New Zealand
Country
New Zealand
Secondary sponsor category [1] 299504 0
None
Name [1] 299504 0
N/A
Address [1] 299504 0
N/A
Country [1] 299504 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300947 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 300947 0
Ethics committee country [1] 300947 0
New Zealand
Date submitted for ethics approval [1] 300947 0
18/03/2018
Approval date [1] 300947 0
18/05/2018
Ethics approval number [1] 300947 0
18/STH/89

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85378 0
Dr Cameron Schauer
Address 85378 0
Counties Manukau District Health Board
C/O Middlemore Hospital
100 Hospital Rd, Otahuhu, Auckland 2025
New Zealand
Country 85378 0
New Zealand
Phone 85378 0
+64210368637
Fax 85378 0
Email 85378 0
[email protected]
Contact person for public queries
Name 85379 0
Cameron Schauer
Address 85379 0
Counties Manukau District Health Board
C/O Middlemore Hospital
100 Hospital Rd, Otahuhu, Auckland 2025
New Zealand
Country 85379 0
New Zealand
Phone 85379 0
+64210368637
Fax 85379 0
Email 85379 0
[email protected]
Contact person for scientific queries
Name 85380 0
Cameron Schauer
Address 85380 0
Counties Manukau District Health Board
C/O Middlemore Hospital
100 Hospital Rd, Otahuhu, Auckland 2025
New Zealand
Country 85380 0
New Zealand
Phone 85380 0
+64210368637
Fax 85380 0
Email 85380 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.