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Trial registered on ANZCTR


Registration number
ACTRN12613000111774
Ethics application status
Approved
Date submitted
29/01/2013
Date registered
30/01/2013
Date last updated
18/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Colomid: Midkine as a predictive marker in colorectal cancer
Scientific title
A study for patients with advanced colorectal cancer, comparing midkine with carcino-embyonic antigen (CEA) and computed tomography (CT) scans to predict response to chemotherapy, and identify early cancer progression
Secondary ID [1] 281852 0
None
Universal Trial Number (UTN)
U1111-1138-9871
Trial acronym
ColoMid
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced or metastatic colorectal cancer 288214 0
Condition category
Condition code
Cancer 288579 288579 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will be allowed to receive whichever chemotherapy regimen thier oncologist recommends. They will be studied for 6 months, or until their cancer progresses, and will have blood tests at 2 weeks and then every 3-4 weeks, whilst receiving chemotherapy for their colorectal cancer. The blood test for midkine involves an extra 12mL (2-3 teaspoons) of blood to be taken, which can be done at the same time as the usual blood tests for monitoring the effects of the chemotherapy. The blood tests can be taken at any Hunter Area Pathology Service (HAPS) collection centre, and will be taken using the same procedure as normal blood tests. There is no need to fast prior to collection. The only extra blood test for midkine is 2 weeks after the first dose of chemotherapy. The interval between blood tests depends on when blood tests are required for the chemotherapy regimen that is being used.

Participants will also receive standard monitoring tests: carcino-embryonic antigen (CEA) every 3-4 weeks and computed tomography (CT) scans every 8 weeks.
Intervention code [1] 286410 0
Not applicable
Comparator / control treatment
All participants will have blood tests for midkine before the first cycle of chemotherapy, at 2 weeks after and then every 3-4 weeks, and have the standard monitoring tests, carcino-embryonic antigen (CEA) every 3-4 weeks and computed tomography (CT) scans every 8 weeks.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288735 0
Response rate to chemotherapy, measured by RECIST 1.1 criteria.
Timepoint [1] 288735 0
6 months
Primary outcome [2] 288736 0
Progression on chemotherapy, as measured by CT scan (RECIST 1.1), CEA or investigator assessment.
Timepoint [2] 288736 0
6 months
Secondary outcome [1] 300864 0
Comparison of serum and plasma midkine, to validate plasma testing, using ELISA kit.
Timepoint [1] 300864 0
6 months

Eligibility
Key inclusion criteria
Ability to give informed consent
Metastatic or locally advanced colorectal cancer
Starting on a new course of chemotherapy for colorectal cancer
Adequate organ function to permit chemotherapy to be given
Life expectancy of more than 3 months
Measurable or non-measurable lesions
Ability to comply with study procedures
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Past history of malignancy, other than non-melanoma skin cancers
Current active inflammatory, autoimmune or infective process

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 506 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 507 0
Newcastle Private Hospital - New Lambton Heights
Recruitment postcode(s) [1] 6248 0
2298 - Waratah
Recruitment postcode(s) [2] 6249 0
2305 - New Lambton Heights

Funding & Sponsors
Funding source category [1] 286632 0
Hospital
Name [1] 286632 0
Calvary Mater Newcastle Hospital
Address [1] 286632 0
2 Edith St
Waratah
NSW 2298
Country [1] 286632 0
Australia
Primary sponsor type
Hospital
Name
Calvary Mater Newcastle Hospital
Address
2 Edith St
Waratah
NSW 2298
Country
Australia
Secondary sponsor category [1] 285417 0
None
Name [1] 285417 0
Address [1] 285417 0
Country [1] 285417 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288711 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 288711 0
Locked Bag No 1
New Lambton
NSW 2305
Ethics committee country [1] 288711 0
Australia
Date submitted for ethics approval [1] 288711 0
10/12/2012
Approval date [1] 288711 0
13/12/2012
Ethics approval number [1] 288711 0
12/12/12/5.05

Summary
Brief summary
This study is recruiting participants with advanced or metastatic colorectal cancer, who are going to start on a new course of chemotherapy. It will investigate a new blood test, called Midkine, and determine if it is better than the standard tests (CEA and CT scans), at identifying whether or not the chemotherapy is effective.

Who is it for?
You may be eligible to join this study if you are 18 years or over, have been diagnosed with metastatic or locally advanced colorectal cancer and due to starting on a new course of chemotherapy. Full inclusion criteria for this study can be found in the appropriate section of this form.

Trial details
In this study, you will be observed for a total period of 6 months, or until your cancer progresses. You will have standard and midkine blood tests before starting chemotherapy, a midkine sample taken at 2 weeks and then standard and midkine blood tests every 3-4 weeks, whilst receiving chemotherapy for your colorectal cancer. The interval between blood tests depends on when blood tests are required for the chemotherapy regimen that is being used. The only extra blood test you will require is for midkine at 2 weeks after starting on the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37390 0
Prof Stephen Ackland
Address 37390 0
Department of Medical Oncology
Calvary Mater Newcastle
Locked Bag No 7
Hunter Regional Mail Centre
NSW 2310
Country 37390 0
Australia
Phone 37390 0
+61 2 49211770
Fax 37390 0
+61 2 49680384
Email 37390 0
stephen.ackland@calvarymater.org.au
Contact person for public queries
Name 37391 0
Ms Kim Adler
Address 37391 0
Clinical Trials
Department of Medical Oncology
Calvary Mater Newcastle
Locked Bag No 7
Hunter Regional Mail Centre
NSW 2310
Country 37391 0
Australia
Phone 37391 0
+61 2 49211375
Fax 37391 0
+61 2 49211460
Email 37391 0
kim.adler@calvarymater.org.au
Contact person for scientific queries
Name 37392 0
Prof Stephen Ackland
Address 37392 0
Department of Medical Oncology
Calvary Mater Newcastle
Locked Bag No 7
Hunter Regional Mail Centre
NSW 2310
Country 37392 0
Australia
Phone 37392 0
+61 2 49211770
Fax 37392 0
+61 2 49680384
Email 37392 0
stephen.ackland@calvarymater.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary