Non-invasive Risk Stratification of CR AMN/SSP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

205 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-11

Study Completion Date

2021-07-31

Brief Summary

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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).

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Detailed Description

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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

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Adenomatous Polyps

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal subjects

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

blood or stool samples will be collected

Intervention Type 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

blood or stool samples will be collected

Intervention Type 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

blood or stool samples will be collected

Intervention Type 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

No interventions assigned to this group

Sessile Serrated Adenoma

blood or stool samples will be collected from people with SSP detected at resection

No interventions assigned to this group

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.

blood or stool samples will be collected

Intervention Type OTHER

blood or stool samples will be collected

Interventions

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blood or stool samples will be collected

Intervention Type OTHER

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes