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
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
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
A Prospective Observational Study of Colorectal Cancer in Counties Manukau District Health Board.

Lal D, Gastroenterology Consultant, CMDHB
Schauer C, Gastroenterology Registrar, CMDHB

Background:

Colorectal cancer (CRC) continues to represent a large health burden both in New Zealand (NZ) and the world. In NZ it represents the second most common cancer registered (14%) and second most frequent cause of cancer related death (14%). In addition, NZ has an internationally low rate of early stage diagnosis with only 28% of disease surgically curable. Colorectal cancer may present insidiously, dependent on symptoms and patient factors. Traditional risk factors, lifestyle factors, ethnic and cultural variability are also important in determining risk.

Currently, only gross incidence and mortality rates are collected by the NZ cancer registry. More complete and specific data from New Zealand is limited. Detailed local epidemiological data, presenting symptoms and signs, risk factors, diagnosis and treatment patterns will be crucial information to assist healthcare providers in assessment of risk and to improve CRC statistics in our area.

Ethics and safety
-Patients will be informed of process of data collection for study purposes and consent obtained. Any patient not wanting data to be stored (data being collected is part of routine history taking) will be excluded.
-Data is confidential and only shared amongst medical staff.
-Data will be safely stored on excel spreadsheet with NHI identification.

Project Management
-Gastroenterology Registrar on ward duty (rotating 3-6 monthly) will be in charge of data collection.
-Dr Lal (Gastroenterology SMO) will be in charge of project overview

Timetable
-Once approved, we intend to commence data collection after dissemination of project protocol to the relevant departments (gastroenterology, pathology, surgery)
-We will collect and review data on a 6 monthly basis – this project is likely to run over a number of years (2-3)

Resources
-We anticipate this to take 1-2 hours/week.
-Use of a biostatistician at the conclusion of the project.

Research Output
-We plan to present data within the department, surgical department and potentially national and international conferences to inform colleagues of findings if data is of use. Dissemination to local general practitioners about symptoms in primary care settings would be of great use.

Trial website
Trial related presentations / publications
Public notes
Prospective enrolment commenced at the time of ethical approval date, however prior to this, retrospective review was being completed of cases to check acceptability and feasibility of the study (obtaining data/follow-up).

69 cases were enrolled, the first of which was 13/02/2018.

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
Dr 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
Dr 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.