ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

None

Universal Trial Number (UTN)

U1111-1217-1457

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Colorectal cancer

Condition category

Condition code

Cancer

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

At time of referral

Primary outcome [2]

-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]

At time of referral

Primary outcome [3]

-Identifying number of patients presenting with certain symptoms/signs:
3) Palpable mass on abdominal or digital rectal examination

Timepoint [3]

At time of referral

Secondary outcome [1]

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]

Immediately following treatment

Secondary outcome [2]

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]

6-12 months post treatment

Secondary outcome [3]

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]

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?

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

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Counties Manukau District Health Board

Address [1]

Counties Manukau District Health Board
C/O Middlemore Hospital
100 Hospital Rd, Otahuhu
Auckland 2025
New Zealand

Country [1]

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]

None

Name [1]

N/A

Address [1]

N/A

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern A Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

18/03/2018

Approval date [1]

18/05/2018

Ethics approval number [1]

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

Dr Cameron Schauer

Address

Counties Manukau District Health Board
C/O Middlemore Hospital
100 Hospital Rd, Otahuhu, Auckland 2025
New Zealand

Country

New Zealand

Phone

+64210368637

Fax

cameron.schauer@gmail.com

Contact person for public queries

Name

Cameron Schauer

Address

Counties Manukau District Health Board
C/O Middlemore Hospital
100 Hospital Rd, Otahuhu, Auckland 2025
New Zealand

Country

New Zealand

Phone

+64210368637

Fax

cameron.schauer@gmail.com

Contact person for scientific queries

Name

Cameron Schauer

Address

Counties Manukau District Health Board
C/O Middlemore Hospital
100 Hospital Rd, Otahuhu, Auckland 2025
New Zealand

Country

New Zealand

Phone

+64210368637

Fax

cameron.schauer@gmail.com

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically