Changes in Stem Cells of the Colon in Response to Increased Risk of Colorectal Cancer
NCT ID: NCT01075893
Last Updated: 2017-10-31
Study Results
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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COMPLETED
11 participants
OBSERVATIONAL
2010-02-28
2012-10-31
Brief Summary
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It is now thought that colorectal cancer cells arise from stem cells where the genetic material regulating growth and division of the stem cell has become defective. This leads to unregulated production of cells which in turn have defective genetic information and cancer formation.
Prior studies have demonstrated that the earliest changes before a cancer develops are changes in cellular proliferation. Now that reliable markers to identify stem cells have been found, the researchers aim to investigate stem cell numbers and changes in distribution in those at normal risk of colorectal cancer and those at higher risk. The researchers hypothesise that changes in cellular proliferation at the top of the crypt in individuals at higher risk of colorectal cancer are due to a change in the number of stem cells in the crypt base.
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Adenomatous polyp
Patients who have begun the polyp-cancer sequence (ie. are in polyp surveillance after excision of a prior adenomatous polyp) will be used to test those patients at higher risk of colorectal.
No interventions assigned to this group
Patients at normal risk of cancer
Patients found to have endoscopically and histological normal mucosa.
No interventions assigned to this group
Ulcerative colitis
Patients who are under surveillance for known ulcerative colitis will be used to test those patients at higher risk of colorectal.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Familial polyposis syndrome
* Lynch syndrome
* Known colorectal tumour
* Previous colorectal resection
* Pregnancy
* Chemotherapy in last 6 months
* Therapy with aspirin/other nonsteroidal anti-inflammatory drug (NSAID)
* Other immunosuppressive medication
* Incomplete left sided examination
* Colorectal carcinoma found at endoscopy
* Iatrogenic perforation at endoscopy
* Colorectal cancer on histology
* Microscopic colitis on histology
For the colitis group
* Simple clinical colitis activity index (SCCAI) score \> 5
18 Years
85 Years
ALL
Yes
Sponsors
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Northumbria Healthcare NHS Foundation Trust
OTHER
Newcastle University
OTHER
Responsible Party
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Principal Investigators
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Iain JD McCallum, MBChB MRCS
Role: PRINCIPAL_INVESTIGATOR
Newcastle University, UK
John C Mathers, PhD
Role: STUDY_CHAIR
Newcastle University, UK
Seamus B Kelly, MD FRCS
Role: STUDY_DIRECTOR
Newcastle University, UK
Mike Bradburn, MD FRCS
Role: STUDY_DIRECTOR
Northumbria NHS foundation trust
Locations
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Wansbeck General Hospital
Ashington, Tyne & Wear, United Kingdom
North Tyneside Hospital
North Shields, Tyne & Wear, United Kingdom
Countries
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References
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Dronamraju SS, Coxhead JM, Kelly SB, Burn J, Mathers JC. Cell kinetics and gene expression changes in colorectal cancer patients given resistant starch: a randomised controlled trial. Gut. 2009 Mar;58(3):413-20. doi: 10.1136/gut.2008.162933. Epub 2008 Oct 31.
Barker N, van Es JH, Kuipers J, Kujala P, van den Born M, Cozijnsen M, Haegebarth A, Korving J, Begthel H, Peters PJ, Clevers H. Identification of stem cells in small intestine and colon by marker gene Lgr5. Nature. 2007 Oct 25;449(7165):1003-7. doi: 10.1038/nature06196. Epub 2007 Oct 14.
Other Identifiers
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McCallum-001
Identifier Type: -
Identifier Source: org_study_id