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Non-invasive Risk Stratification of CR AMN/SSP (FIT)

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ClinicalTrials.gov Identifier: NCT02476682
Recruitment Status : Recruiting
First Posted : June 19, 2015
Last Update Posted : March 23, 2021
Sponsor:
Information provided by (Responsible Party):
Professor Michael Bourke, Western Sydney Local Health District

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).

Condition or disease Intervention/treatment
Adenomatous Polyps Other: blood or stool samples will be collected

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.

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Study Type : Observational
Estimated Enrollment : 1725 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Stool and Blood Based Tests for Colorectal Advanced Mucosal Neoplasia
Actual Study Start Date : January 11, 2016
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Group/Cohort Intervention/treatment
Normal subjects
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

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
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
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
blood or stool samples will be collected




Primary Outcome Measures :
  1. Demographics [ Time Frame: 1 day ]
    Data to adequately describe demographic situations of each participant.

  2. 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.

  3. 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.

  4. Demographics [ Time Frame: 1 day ]
    Data to adequately decribe the clinical situations of each participant.


Biospecimen Retention:   Samples With DNA
2mg of stool per patient 18mL of blood per patient


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study population will be comprised of subjects diagnosed with AMN/SSP and subjects scheduled for screening colonoscopy.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476682


Contacts
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Contact: Rebecca Sonson, BN MPH 0298455555 ext 59779 Rebecca.Sonson@health.nsw.gov.au
Contact: Michael J Bourke, MBBS, FRACP 98455555 ext 59779 bec2153@gmail.com

Locations
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Australia, New South Wales
Westmead Endoscopy Unit Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Kathleen Goodrick, BN MPH    0298455555    Kathleen.Goodrick@health.nsw.gov.au   
Contact: Michael Bourke, MBBS    0298455555      
Sponsors and Collaborators
Professor Michael Bourke
Investigators
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Principal Investigator: Michael J Bourke, MBBS FRACP Westmead Hospita;
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Responsible Party: Professor Michael Bourke, Director of Gastrointestinal Endoscopy, Western Sydney Local Health District
ClinicalTrials.gov Identifier: NCT02476682    
Other Study ID Numbers: HREC2014/9/4.4(4079)
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021
Keywords provided by Professor Michael Bourke, Western Sydney Local Health District:
Sessile serrated polyps
Advanced mucosal neoplasia
Additional relevant MeSH terms:
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Adenomatous Polyps
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms