Trial from ClinicalTrials.gov

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Trial ID
NCT02476682
Ethics application status
Date submitted
10/06/2015
Date registered
10/06/2015
Date last updated
15/12/2015

Titles & IDs
Public title
Non-invasive Risk Stratification of CR AMN/SSP
Scientific title
Evaluation of Stool and Blood Based Tests for Colorectal Advanced Mucosal Neoplasia
Secondary ID [1] 0 0
HREC2014/9/4.4(4079)
Universal Trial Number (UTN)
Trial acronym
FIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adenomatous Polyps 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 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
Other interventions - blood or stool samples will be collected

Normal subjects - blood or stool samples will be collected from people referred for screening colonoscopy

Colorectal cancer - blood or stool samples will be collected from people with colorectal cancer detected at colonoscopy or resection

Polyps <10mm and no high risk features - blood or stool samples will be collected from people with no polyps or low risk polyps (<10mm, no villous component or dysplasia) detected at colonoscopy

Advanced Mucosal Neoplasia - blood or stool samples will be collected from people with AMN detected at resection

Sessile Serrated Adenoma - blood or stool samples will be collected from people with SSP detected at resection

non-colorectal neoplastic disease - Participants with disease that is not colorectal neoplasia. Analysis of this cohort is not a primary endpoint but the investigators will report assay positivity in this group on an opportunistic basis. This cohort will include patients diagnosed with, for example, inflammatory bowel disease or extracolonic cancer.


Other interventions: blood or stool samples will be collected
blood or stool samples will be collected

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Demographics - Data to adequately describe demographic situations of each participant.
Timepoint [1] 0 0
1 day
Primary outcome [2] 0 0
Level of methylated DNA in circulation - The process will use an automated extraction procedure incorporating state-of-the-art magnetic silica-coated beads on a QIASymphony (Qiagen). The extracted DNA is bisulphite-converted and further purified (automated on a QIACube HT liquid handler) prior to analyzing 12uL of bis-DNA in a multi-plexed (BCAT1, IKZF1, ACTB (control assay)) real-time PCR for measuring the methylation levels of target amplicons.
Timepoint [2] 0 0
5 years
Primary outcome [3] 0 0
Level of haemoglobin in stool - Suspended stool collected in the HM-JACKarc sampling device will be processed for Hb measurements using commercially available reagents and the bench-top analyser instrument, HM-JACKarc, according to manufacturer recommendation (Kyowa Medex Co Ltd, Japan). Measured haemoglobin concentrations will be reported as ug Hb/g stool. A 20 ug Hb/g stool a cut-off concentration will be used for qualitative reporting.
Timepoint [3] 0 0
5 years
Primary outcome [4] 0 0
Demographics - Data to adequately decribe the clinical situations of each participant.
Timepoint [4] 0 0
1 day

Eligibility
Key inclusion criteria
- Individuals capable and willing of proving satisfactory informed consent

- Individuals with colonic lesions larger than 20mm

- Individuals diagnosed with laterally spreading or sessile polyp morphology

- Individuals schedules for screening colonoscopy and with no prior history of CRC

- Ability and willingness to collect stool sample at home

- Ability and willingness to undergo venepuncture procedure
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Individuals not able or unwilling to provide informed consent

- Individuals less than 18 year of age

- Individuals who undergo an incomplete colonoscopy or resection, which raises doubt as
to the status of the colon (post-hoc exclusion)

- Individuals with a prior history of CRC

- Individuals with a history of Irritable Bowel Disease (IBD), hereditary nonpolyposis
colorectal cancer (HNPCC) or Familial adenomatous polyposis (FAP)

- Individuals with bleeding diathesis

- Pregnancy

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Endoscopy Unit - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Professor Michael Bourke
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the clinical utility of stool and blood methylation
tests for detection of advanced mucosal neoplasia (AMN) and sessile serrated polyps (SSP).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael J Bourke, MBBS FRACP
Address 0 0
Westmead Hospita;
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rebecca Sonson, BN MPH
Address 0 0
Country 0 0
Phone 0 0
0298455555
Fax 0 0
Email 0 0
Rebecca.Sonson@health.nsw.gov.au
Contact person for scientific queries
Contact person responsible for updating information