Adenomatous PolypsFITNCT02476682
Non-invasive Risk Stratification of CR AMN/SSP
An observational study of Adenomatous Polyps, run by Professor Michael Bourke at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adenomatous Polyps
- What is being tested?
- blood or stool samples will be collected
- How many people
- 205 participants
- Where
- 1 siteAustralia
- Study dates
- 11 Jan 2016to Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be comprised of subjects diagnosed with AMN/SSP and subjects scheduled for screening colonoscopy.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Stool and Blood Based Tests for Colorectal Advanced Mucosal Neoplasia
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).
Read the detailed description
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.
- Conditions
- Adenomatous Polyps
- Being tested
- blood or stool samples will be collected
- Keywords
- Sessile serrated polyps, Advanced mucosal neoplasia
- Medical subject headings
- Adenomatous Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood or stool samples will be collectedOther
blood or stool samples will be collected
| Study group | Role | What they receive |
|---|---|---|
| Normal subjects | blood or stool samples will be collected from people referred for screening colonoscopy Receives: Other: blood or stool samples will be collected | |
| Colorectal cancer | blood or stool samples will be collected from people with colorectal cancer detected at colonoscopy or resection Receives: Other: blood or stool samples will be collected | |
| 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 Receives: Other: blood or stool samples will be collected | |
| 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. Receives: Other: blood or stool samples will be collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics
Data to adequately describe demographic situations of each participant.
Measured: 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.
Measured: 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.
Measured: 5 years
Demographics
Data to adequately decribe the clinical situations of each participant.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study start11 Jan 2016
- Primary completionJul 2020
- Study completionJul 2021
Why it stopped: facility required for analysis of samples is no longer able to facilitate analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenomatous PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Michael Bourke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Professor Michael Bourke, Western Sydney Local Health District
- Investigators
- Michael J Bourke, MBBS FRACP, Principal investigator, Westmead Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476682
- Sponsor's protocol ID
- HREC2014/9/4.4(4079)
- Acronym
- FIT
- Status last verified
- Mar 2025
- First submitted
- 10 Jun 2015
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Stool and Blood Based Tests for Colorectal Advanced Mucosal Neoplasia
- ClinicalTrials.gov ID
- NCT02476682
- Acronym / sponsor ID
- FIT / HREC2014/9/4.4(4079)
- Conditions
- Adenomatous Polyps
- Keywords
- Sessile serrated polyps, Advanced mucosal neoplasia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: facility required for analysis of samples is no longer able to facilitate analysis
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Professor Michael BourkeUniversity, hospital or other
- Study start
- 11 Jan 2016 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Normal subjects | – | Other: blood or stool samples will be collectedblood or stool samples will be collected from people referred for screening colonoscopy |
| Colorectal cancer | – | Other: blood or stool samples will be collectedblood or stool samples will be collected from people with colorectal cancer detected at colonoscopy or resection |
| Polyps <10mm and no high risk features | – | Other: blood or stool samples will be collectedblood 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 | – | Other: blood or stool samples will be collectedParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be comprised of subjects diagnosed with AMN/SSP and subjects scheduled for screening colonoscopy.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood or stool samples will be collectedblood or stool samples will be collected | Other | Colorectal cancer, Normal subjects, Polyps <10mm and no high risk features, non-colorectal neoplastic disease |
Primary outcome
Demographics
Time frame: 1 day
Data to adequately describe demographic situations of each participant.
Level of methylated DNA in circulation
Time frame: 5 years
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.
Level of haemoglobin in stool
Time frame: 5 years
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.
Demographics
Time frame: 1 day
Data to adequately decribe the clinical situations of each participant.
Results and safety
The study was stopped early (reason given: facility required for analysis of samples is no longer able to facilitate analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
Related trials for Adenomatous Polyps
RecruitingPhase 1
Testing for Safety and Colorectal Cancer Preventive Effects of ONC201
Colorectal Adenomatous Polyp, Colorectal Carcinoma
Recruiting
Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)
Colorectal Cancer, Colorectal Polyp
Enrolling by invitation
Investigation of β-hydroxybutyrate Supplementation as Chemoprevention in Familial Adenomatous Polyposis
FAP, Familial Adenomatous Polyposis
RecruitingObservational study
Early Detection of Advanced Adenomas and Colorectal Cancer
Colorectal Cancer, Colorectal Neoplasms
Not yet recruiting
STSC-HybridAPC Trial
Colon Adenomas, Colon Adenomatous Polyp
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Bourke, MBBS FRACP principal investigator
Westmead Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenomatous Polyps, run by Professor Michael Bourke at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: facility required for analysis of samples is no longer able to facilitate analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographics (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.