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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
13/06/2023
Date data sharing statement initially provided
11/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Determining the accuracy of non-invasive biomarkers for detecting pre-cancerous colorectal neoplasia
Scientific title
Determining the accuracy of non-invasive biomarkers for detecting pre-cancerous colorectal neoplasia
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
Inflammatory Bowel Disease 326595 0
Pre-cancerous colorectal neoplasia 330356 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
Oral and Gastrointestinal 323842 323842 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will discover and develop novel blood & stool biomarkers. Biomarkers will be evaluated for both their ability and acceptability to detect inflammation, adenomas, and cancer in patients with gastrointestinal symptoms. The development of new screening tests will help guide doctors in determining which symptomatic patients need colonoscopy.
People experiencing gastrointestinal symptoms, have had a microscopic rectal bleed (by indication of a positive faecal occult blood test), or living with inflammatory bowel disease who are booked for a colonoscopy at our study sites will be pre-screened for eligibility.
An invitation letter will be sent to eligible individuals, accompanied by a faecal immunochemical test (FIT) kit, questionnaire, and participant information & consent form. Participants may be met before their colonoscopy appointment by a member of the research team to have a short medical history interview & a blood sample taken. Participants may also provide a stool sample prior to their colonoscopy. Samples of tissue (biopsies) may be requested from colonoscopy by opt-in consent.
Candidate biomarkers (which indicate presence of pathological change in the bowel) will be identified from molecular analyses on tissue samples. Stool and blood samples will be subsequently analysed to determine the lead biomarkers, with results compared to the findings at 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
People booked for a colonoscopy at our approved study sites who are:
- Aged 18 years or over, and
- Experiencing gastrointestinal symptoms such as: abdominal pain, a change in bowel habit, weight loss, rectal bleeding (inclusive of microscopic rectal bleeding such as a positive faecal occult blood test), iron deficiency/anaemia, and/or gastrointestinal inflammation, OR living with inflammatory bowel disease, and
- Willing and able to provide a blood, stool, and/or tissue sample
Minimum age
18 Years
Maximum age
No limit
Sex
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, Wilcoxon rank-sum test, or Pearson Chi square test as appropriate.
Correlations between the biomarker levels of the tissue, blood and stool samples, as well as stage of disease will be assessed with Spearman 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
24/06/2020
Actual
24/06/2020
Date of last participant enrolment
Anticipated
27/04/2025
Actual
Date of last data collection
Anticipated
27/05/2025
Actual
Sample size
Target
3000
Accrual to date
985
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 hospital [4] 22513 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 30234 0
5042 - Bedford Park
Recruitment postcode(s) [2] 30235 0
5168 - Noarlunga Centre
Recruitment postcode(s) [3] 30236 0
5037 - Kurralta Park
Recruitment postcode(s) [4] 37754 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 305691 0
Charities/Societies/Foundations
Name [1] 305691 0
Flinders Foundation Seeding Grant
Country [1] 305691 0
Australia
Funding source category [2] 311603 0
Government body
Name [2] 311603 0
National Health and Medical Research Council
Country [2] 311603 0
Australia
Funding source category [3] 314079 0
Hospital
Name [3] 314079 0
The Hospital Research Foundation Group
Country [3] 314079 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 develop new and simple ways to screen which patients with bowel symptoms, inflammation, or anaemia will need a colonoscopy using a novel biomarker test. These results can help reduce the need for colonoscopy, and prioritising it for those that need it most.

Who is it for?
You may be eligible for this study if you are an adult who is booked for a colonoscopy at participating hospitals because you have bowel symptoms, a positive faecal occult blood test, iron deficiency/anaemia, or inflammation, inclusive of people living with inflammatory bowel disease.

Study details:
After completing a consent form, participants may be provided a faecal immunochemical test (FIT) kit and questionnaire for completion. Participants may also be met before their colonoscopy to have a short medical history interview & blood sample taken. Optionally, tissue samples may also be requested from the colonoscopy, Samples will be analysed for biomarkers which might indicate that there is inflammation, cancer, or polyp in the bowel. Biomarker results will be compared to colonoscopy findings.

Sometimes there are long waiting lists for colonoscopies. The development of novel biomarker tests will help guide doctors in determining which patients need colonoscopy.
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
[email protected]
Contact person for public queries
Name 102251 0
Rachel Parker
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 882751075
Fax 102251 0
+61 8 8204 6330
Email 102251 0
[email protected]
Contact person for scientific queries
Name 102252 0
Geraldine Laven-Law
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 8275 1075
Fax 102252 0
+61 8 8204 6330
Email 102252 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?
De-identified participant data underlying published results
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Publicly available
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Online bio-repository (i.e. NCBI GEO; https://www.ncbi.nlm.nih.gov/geo/ or other related online bio-repository as per journal publication requirements)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7909Ethical approval  [email protected]



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.