Non-invasive Risk Stratification of CR AMN/SSP

NCT02476682 | Terminated

• 1 other identifier: HREC2014/9/4.4(4079)
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 1

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).

Conditions

Adenomatous Polyps

Keywords

Sessile serrated polyps; Advanced mucosal neoplasia

Outcome Measures

Primary Outcomes (4)

• Demographics

  Data to adequately describe demographic situations of each participant.

  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.

  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.

  5 years

• Demographics

  Data to adequately decribe the clinical situations of each participant.

  1 day

Study Arms (6)

Normal subjects

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

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

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

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.

Other: blood or stool samples will be collected

Interventions

blood or stool samples will be collected OTHER

blood or stool samples will be collected

Colorectal cancer; Normal subjects; Polyps <10mm and no high risk features; non-colorectal neoplastic disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will be comprised of subjects diagnosed with AMN/SSP and subjects scheduled for screening colonoscopy.

You may qualify if:

• 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

You may not qualify if:

• Individuals not able or unwilling to provide informed consent
• Individuals less than 18 year of age
• 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

Sponsors & Collaborators

• Professor Michael Bourke: lead

Study Sites (1)

Westmead Endoscopy Unit

Westmead, New South Wales, 2145, Australia

Location

Biospecimen

Retention: SAMPLES WITH DNA

2mg of stool per patient 18mL of blood per patient

MeSH Terms

Conditions

Adenomatous Polyps

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Michael J Bourke, MBBS FRACP

  Westmead Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Gastrointestinal Endoscopy

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 19, 2015
• Study Start: January 11, 2016
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2021
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

AU (1)