Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000413628
Ethics application status
Approved
Date submitted
7/03/2023
Date registered
26/04/2023
Date last updated
23/06/2024
Date data sharing statement initially provided
26/04/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The COPPER Trial: Comparision of a tumour marker in patients with appendix or right sided colon cancer
Scientific title
COmparison of carcinoembryonic antigen levels between Portal and PERipheral blood in patients with appendiceal or right sided colon cancer (The COPPER Trial)
Secondary ID [1] 309142 0
Nil known
Universal Trial Number (UTN)
U1111-1289-4006
Trial acronym
The COPPER trial (COmparison of carcinoembryonic antigen levels between Portal and PERipheral blood in patients with appendiceal or right sided colon cancer)
Linked study record
Nil known

Health condition
Health condition(s) or problem(s) studied:
Appendiceal cancer 329242 0
Colon cancer 329243 0
Condition category
Condition code
Cancer 326199 326199 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 326200 326200 0 0
Other cancer types
Blood 326201 326201 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The only intervention will be to take five ml of blood will be taken from a vein in the patient's arm (this will be from a intravenous cannula as part of the patient's general anaesthetic such that there will be no additional venepuncture burden) as well as another 5 ml of blood from the ileocolic / appendicular vein (a blood vessel that drains blood from the appendix or right colon that is located in the right lower side of the abdomen) during the initial stages of your peritonectomy surgery (total number of blood tests: 2; total volume: 10ml; NB: 5-10mL is equivalent to 1-2 teaspoons). The blood sampling would take less than one minute during surgery by the anaesthetist (peripheral sample) and the surgeon (portal vein sample). Assessment of the fidelity of this intervention will be in part by testing for albumin of these specimens for comparison.
Intervention code [1] 325591 0
Diagnosis / Prognosis
Intervention code [2] 325646 0
Early detection / Screening
Intervention code [3] 325647 0
Treatment: Other
Comparator / control treatment
Portal vein carcino-embryonic antigen (CEA) and peripheral vein CEA from appendiceal cancer patients will be compared as will those CEA levels from right sided colon cancer patients. We intend to note if one group or the other or neither or both have any significant differences between the portal vein and peripheral vein CEA levels. Peripheral vein CEA will be the comparator with albumin taken at the same time for quality assessment comparisons between specimens as a reference range
Control group
Active

Outcomes
Primary outcome [1] 334077 0
Carcinoembryonic antigen (CEA) levels determined from the portal vein
Timepoint [1] 334077 0
Blood samples to be collected during surgery
Primary outcome [2] 334202 0
Carcinoembryonic antigen (CEA) levels determined from the peripheral vein
Timepoint [2] 334202 0
Blood samples to be collected during surgery
Primary outcome [3] 334203 0
Albumin levels determined from the peripheral and portal vein as a composite primary outcome for correlation..
Timepoint [3] 334203 0
Blood samples to be collected during surgery
Secondary outcome [1] 419288 0
Immunohistochemical and histopathological (i.e., differentiation, node metastasis, lymphovascular invasion, etc) variables of the primary appendiceal and right sided colon cancer by NSW Health pathology as part of routine histopathological reporting - Composite secondary outcomes
Timepoint [1] 419288 0
Tumour samples to be collected during surgery
Outcomes measured throughout hospital stay and during outpatient follow-up and surveillance, e.g., 6- and 12-monthly post-surgery follow-up then yearly for 5 years

Eligibility
Key inclusion criteria
* Sex: All
* Age range: 18 years and above
* Disease status: Appendiceal or right sided colon cancer (suspected or confirmed)
* Willingness to give written informed consent and willingness to participate to and comply with the study.
* Pre-operative carcino-embryonic antigen (CEA) level > 5 microg/L
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants who cannot provide informed consent.
* Patients who have had a previous peritonectomy (including those who have previously undergone a right hemicolectomy).

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Nil known
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil known
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil known
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on the Tabuchi et al, study, mean CEA level for portal vein samples were 26.6 ± 6.4 ng/mL and 8.1 ± 1.9 ng/mL for peripheral vein samples.1 Using these values, an enrollment ratio of 1, alpha value of 0.05, power set to 90%, with a continuous endpoint, as a two independent sample study, the estimated total sample size is 6 patients.2

1. TABUCHI, Y ET AL. “COMPARISON OF CARCINOEMBRYONIC ANTIGEN LEVELS BETWEEN PORTAL AND PERIPHERAL BLOOD IN PATIENTS WITH COLORECTAL CANCER. CORRELATION WITH HISTOPATHOLOGIC VARIABLES.” CANCER VOL. 59,7 (1987): 1283-8. DOI:10.1002/1097-0142(19870401)59:7<1283::AID-CNCR2820590709>3.0.CO;2-G
2. ROSNER B. FUNDAMENTALS OF BIOSTATISTICS. 7TH ED. BOSTON, MA: BROOKS/COLE; 2011.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
19/07/2022
Date of last participant enrolment
Anticipated
19/07/2029
Actual
Date of last data collection
Anticipated
19/08/2029
Actual
Sample size
Target
15
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24212 0
St George Hospital (QLD) - St George
Recruitment postcode(s) [1] 39745 0
4487 - St George

Funding & Sponsors
Funding source category [1] 313343 0
Hospital
Name [1] 313343 0
St George Hospital Fund
Country [1] 313343 0
Australia
Primary sponsor type
Individual
Name
Professor David Morris
Address
Department of Surgery
St George Hospital
Pitney Building
Short street
KOGARAH NSW 2217
Australia
Country
Australia
Secondary sponsor category [1] 315091 0
None
Name [1] 315091 0
Address [1] 315091 0
Country [1] 315091 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312565 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 312565 0
District Executive Unit, Level4
The Sutherland Hospital & Community Health Service
Cnr The Kingsway & Kareena Road
Caringbah
NSW
2229
Ethics committee country [1] 312565 0
Australia
Date submitted for ethics approval [1] 312565 0
20/04/2022
Approval date [1] 312565 0
06/05/2022
Ethics approval number [1] 312565 0

Summary
Brief summary
The purpose of this study is to explore the differences in a type of tumour marker, called a carcinoembryonic antigen, in two different blood sample sites.

Who is it for?
You may be eligible for this study if you are an adult who has been diagnosed with cancer of either the colon or appendix.

Study details
All participants in this study will be asked to provide consent for venous blood samples to be taken as part of your peritonectomy surgery. Five ml of blood will be taken from a vein in your arm as well as another 5 ml of blood from the vein near your appendix or right colon that is located in the right lower side of the abdomen during the initial stages of your peritonectomy surgery.

All participants will also give access to medical records to collect the relevant study data such as demographic details, diagnosis, treatment, blood and histopathological results.

It is hoped that this research will form part of the eventual outcome where we hope to identify patients at risk of developing liver metastases from their colorectal cancer and develop a suitable drug to prevent these patients from developing liver metastases - Improving their prognosis and disease free survival.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125110 0
Dr Adam Cristaudo
Address 125110 0
St George Hospital, Gray St, Kogarah NSW 2217.
Country 125110 0
Australia
Phone 125110 0
+61 02 9113 2070
Fax 125110 0
Email 125110 0
[email protected]
Contact person for public queries
Name 125111 0
Adam Cristaudo
Address 125111 0
St George Hospital, Gray St, Kogarah NSW 2217.
Country 125111 0
Australia
Phone 125111 0
+61 02 9113 2070
Fax 125111 0
Email 125111 0
[email protected]
Contact person for scientific queries
Name 125112 0
Adam Cristaudo
Address 125112 0
St George Hospital, Gray St, Kogarah NSW 2217.
Country 125112 0
Australia
Phone 125112 0
+61 02 9113 2070
Fax 125112 0
Email 125112 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient age, sex, peripheral and portal vein CEA levels, characteristics of tumour and operation - all deidentified
When will data be available (start and end dates)?
Start date: 6/5/2022 (in line with ethical approval); No end date, available for 5 years after publication
Available to whom?
individual participant data will only be available to those who access all future publications and presentations - deidentified
Available for what types of analyses?
For research purposes only - deidenitified
How or where can data be obtained?
individual participant data will only be available to those who access all future publications and presentations - deidentified


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18522Informed consent form    385513-(Uploaded-07-03-2023-11-59-01)-Study-related document.doc
18523Study protocol    385513-(Uploaded-07-03-2023-11-59-15)-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
SourceTitleYear of PublicationDOI
Dimensions AIComparison Of carcinoembryonic antigen levels between Portal and PERipheral blood in patients with appendiceal adenocarcinoma (COPPER) trial2024https://doi.org/10.1093/bjs/znae052
N.B. These documents automatically identified may not have been verified by the study sponsor.