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Trial registered on ANZCTR


Registration number
ACTRN12620000668909
Ethics application status
Approved
Date submitted
9/05/2020
Date registered
11/06/2020
Date last updated
1/12/2020
Date data sharing statement initially provided
11/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Determining the accuracy of biomarkers in detecting cancer and adenomas in those with gastrointestinal symptoms.
Scientific title
Determining the accuracy of biomarkers in detecting cancer and adenomas in those with gastrointestinal symptoms.
Secondary ID [1] 301243 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CYSP20
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel Cancer Surveillance 317410 0
Colorectal Cancer 317411 0
Condition category
Condition code
Cancer 315512 315512 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Public Health 315513 315513 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will determine the accuracy of biomarkers in blood & stool samples to detect cancer & adenomas (neoplasia) in patients with gastrointestinal symptoms. The development of new screening tests will help guide doctors in determining which symptomatic patients need colonoscopy.
Eligible invitees will be symptomatic patients, booked for colonoscopy at FMC or NHS.
Participants booked for colonoscopy will be pre-screened for eligibility. An invitation letter will be sent to eligible individuals, accompanied by a faecal immunochemical test (FIT) kit and participant information & consent form. Enrolled study participants will be met before their colonoscopy appointment by a research nurse to have a short medical history & blood sample taken. Samples of tissue (biopsies) will be requested from colonoscopy, which
will be an opt-in consent. Tissue samples (biopsies as well as clinically collected pathology samples) will be analysed for changes to molecules (such as DNA, RNA or proteins=“biomarkers”) which will indicate the presence of neoplasia in the bowel. Promising biomarkers will then be analysed for their levels in the stool & blood samples, with results
compared to the findings at the colonoscopy.
Intervention code [1] 317541 0
Early Detection / Screening
Intervention code [2] 317542 0
Diagnosis / Prognosis
Comparator / control treatment
colonoscopy is the gold standard comparator
Control group
Active

Outcomes
Primary outcome [1] 323754 0
Blood biomarker levels (BCAT1 and IKZF1) will be assessed as a composite outcome, to indicate the presence of adenoma.
Timepoint [1] 323754 0
assessed within 1 - 2 weeks before colonoscopy.
Primary outcome [2] 323755 0
Faecal haemoglobin level as assessed by FIT test.
Timepoint [2] 323755 0
assessed within 1 - 2 weeks before the colonoscopy.
Secondary outcome [1] 382791 0
Severity of colonic lesions as assessed by colonoscopy.
Timepoint [1] 382791 0
assessed 1 - 2 days post colonoscopy.
Secondary outcome [2] 382792 0
The accuracy of blood and stool biomarkers will be assessed by comparing to colorectal cancer diagnosis determined by colonoscopy.
Timepoint [2] 382792 0
assessed 1 - 2 days post colonoscopy.

Eligibility
Key inclusion criteria
Patients booked for a colonoscopy within the next month.
Males and females aged 18 years or over
Presenting with symptoms such as: abdominal pain, change in bowel habit, weight loss, rectal bleeding or iron deficiency anaemia.
Willing and able to provide one or more of the samples as required.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Blood, stool and tissue biomarker levels will be compared with the different colonoscopy findings using a non-parametric ANOVA.
Correlations between the biomarker levels of the tissue, blood and stool samples, as well as stage of disease will be assessed with a Spearman Rank correlation.
Variables that are associated with the presence of the biomarkers (such as stage of disease, location of lesion, etc) will be assessed with multiple logistic regression analysis.
Sensitivity, specificity, positive predictive value and negative predictive value, as well as area under the curve of ROC curves will be assessed for all biomarkers and panels of biomarkers.
A p value less than 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Recruiting
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)
SA
Recruitment hospital [1] 16639 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 16640 0
Noarlunga Health Service - Noarlunga Centre
Recruitment hospital [3] 16641 0
Tennyson Centre Day Hospital - Kurralta Park
Recruitment postcode(s) [1] 30236 0
5037 - Kurralta Park
Recruitment postcode(s) [2] 30234 0
5042 - Bedford Park
Recruitment postcode(s) [3] 30235 0
5168 - Noarlunga Centre

Funding & Sponsors
Funding source category [1] 305691 0
Charities/Societies/Foundations
Name [1] 305691 0
Flinders Foundation Seeding Grant
Address [1] 305691 0
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country [1] 305691 0
Australia
Primary sponsor type
University
Name
Flinders University of South Australia
Address
Sturt Road,
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 306103 0
University
Name [1] 306103 0
Flinders University of South Australia
Address [1] 306103 0
Sturt Road,
Bedford Park SA 5042
Country [1] 306103 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305969 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 305969 0
Southern Adelaide Local Health Network
Office for Research
Level 6 / Room 6A - 219
Flinders Medical Centre
Bedford Park SA 5042
Ethics committee country [1] 305969 0
Australia
Date submitted for ethics approval [1] 305969 0
17/02/2020
Approval date [1] 305969 0
27/04/2020
Ethics approval number [1] 305969 0
35.20

Summary
Brief summary
The purpose of this study is to determine if proteins and molecules (otherwise known as biomarkers) found in stool, blood, and tissue samples are able to indicate whether there is a cancer or polyp in the bowel.

Who is it for?
You may be eligible for this study if you are an adult who is booked for a colonoscopy in the next month, at participating hospitals, and are experiencing gastrointestinal symptoms (e.g. abdominal pain, change in bowel habit, weight loss, rectal bleeding or iron deficiency anaemia).

Study details
After completing a consent form, all participants will complete a faecal immunochemical test (FIT) kit. Participants will also be met before their colonoscopy to have a short medical history & blood sample taken. Samples of tissue will be requested from the colonoscopy, and results of all samples will be compared to the findings at the colonoscopy.

It is hoped that this study will help determine if biomarkers can be used to accurately detect cancer and polyps. This will be beneficial as sometimes there are long waiting lists for colonoscopies, and many who have colonoscopies do not find anything significant as symptoms can also be caused by many other conditions such as irritable bowel disease, diverticulitis, ulcers and colitis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102250 0
A/Prof Erin Symonds
Address 102250 0
Bowel Health Service
Level 3, Flinders Centre for Innovation in Cancer
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country 102250 0
Australia
Phone 102250 0
+61 8 8404 2813
Fax 102250 0
+61 8 8204 6330
Email 102250 0
Erin.Symonds@sa.gov.au
Contact person for public queries
Name 102251 0
Ms Kathryn Cornthwaite
Address 102251 0
Bowel Health Service
Level 3, Flinders Centre for Innovation in Cancer
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country 102251 0
Australia
Phone 102251 0
+61 8 8204 5534
Fax 102251 0
+61 8 8204 6330
Email 102251 0
Kathryn.Cornthwaite@sa.gov.au
Contact person for scientific queries
Name 102252 0
A/Prof Erin Symonds
Address 102252 0
Bowel Health Service
Level 3, Flinders Centre for Innovation in Cancer
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country 102252 0
Australia
Phone 102252 0
+61 8 8404 2813
Fax 102252 0
+61 8 8204 6330
Email 102252 0
Erin.Symonds@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual data / or any raw data will be shared without appropriate future consent and / or ethical approval.
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7909 0
Ethical approval
Citation [1] 7909 0
Link [1] 7909 0
Email [1] 7909 0
erin.symonds@sa.gov.au
Other [1] 7909 0
Attachment [1] 7909 0
Summary results
No Results