An observational study in Adenomatous Polyps, sponsored by Professor Michael Bourke. Terminated at 1 site in Australia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-27.
Sponsored by Professor Michael Bourke · Observational
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).
By not only diagnosing colorectal cancer (CRC) at an early stage, but also removing precursor lesions (adenomas), colonoscopy with polypectomy reduces the risk of developing and dying from CRC. Approximately 90% of polyps are less than 10 mm and are easily removed by competent endoscopists. Laterally spreading lesions (LST) and sessile lesions of the colon, also known as advanced mucosal neoplasia (AMN) are underrecognised types of lesions that are more likely to progress to cancer. They include sessile serrated polyps (SSP), an emerging entity of flat polyps with malignant potential. Detection of hemoglobin (a component of blood) in stool is an established validated screening tool for CRC. Its specific role in the prediction of AMN, and particularly SSPs is yet to be defined. Blood tests measuring the level of tumour derived methylated deoxyribonucleic acid (DNA) in blood circulating have been demonstrated to have clinical utility for detection of CRC and AMN. A blood based CRC screening test has the potential to increase compliance. This study aims to determine the clinical utility of stool and blood methylation tests for detection of AMN and SSPs. Stool and blood will be obtained from consenting patients referred for endoscopic removal of known ANM and SSP (study arm) as well as from consenting patients scheduled for colonoscopy screening (control arm). The level of stool hemoglobin and methylated tumour derived DNA in circulation will be measured in the two study groups. Cutoff values will be generated to assess best predictive capability of high risk lesions based on these tests.
79 studies on the registry are indexed under Adenomatous Polyps; 9 are open to participants now.
This study's enrollment of 205 is below the median of 1,000 across 25 observational studies indexed under Adenomatous Polyps.
Browse Adenomatous Polyps studies →Professor Michael Bourke is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will be comprised of subjects diagnosed with AMN/SSP and subjects scheduled for screening colonoscopy.
Exclusion Criteria:
blood or stool samples will be collected from people referred for screening colonoscopy
Other: blood or stool samples will be collected
blood or stool samples will be collected from people with colorectal cancer detected at colonoscopy or resection
Other: blood or stool samples will be collected
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
Other: blood or stool samples will be collected
blood or stool samples will be collected from people with AMN detected at resection
blood or stool samples will be collected from people with SSP detected at resection
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: blood or stool samples will be collected
blood or stool samples will be collected
Demographics
Data to adequately describe demographic situations of each participant.
Time frame: 1 day
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.
Time frame: 5 years
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.
Time frame: 5 years
Demographics
Data to adequately decribe the clinical situations of each participant.
Time frame: 1 day
This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Professor Michael Bourke