Clinical trial NCT02476682: Non-invasive Risk Stratification of CR AMN/SSP
Official title: Evaluation of Stool and Blood Based Tests for Colorectal Advanced Mucosal Neoplasia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Adenomatous Polyps
Keywords: Sessile serrated polyps
Advanced mucosal neoplasia
Lead sponsor: Western Sydney Local Health District
Sponsor class: OTHER
First posted: 2015-06-19
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be comprised of subjects diagnosed with AMN/SSP and subjects scheduled for screening colonoscopy.

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Demographics
timeFrame: 1 day
measure: Level of methylated DNA in circulation
timeFrame: 5 years
measure: Level of haemoglobin in stool
timeFrame: 5 years
measure: Demographics
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Westmead Endoscopy Unit
state: New South Wales
Study officials:
affiliation: Westmead Hospital
name: Michael J Bourke, MBBS FRACP
role: PRINCIPAL_INVESTIGATOR
References: