Changes in Stem Cells of the Colon in Response to Increased Risk of Colorectal Cancer
Recruitment status was Active, not recruiting
Colorectal cancer is a common disease worldwide. Increasing evidence is demonstrating that colorectal cancers arise from 'cancer stem cells.' Stem cells in the colon reside at the bottom of thousands of microscopic crypts throughout the wall of the colon. They create all the cells lining the bowel wall. These cells are created in the base of the crypt and ascend to the top acquiring the characteristics of mature cells of the bowel wall as they ascend.
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Changes in Stem Cells of the Colon in Response to Increased Risk of Colorectal Cancer|
- Number of stem cells in the colonic crypt [ Time Frame: On day of endoscopy ] [ Designated as safety issue: No ]
- Stem cell position in colonic crypt [ Time Frame: On day of endoscopy ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Rectal pinch biopsies - x 9 (10 cm from anal verge)
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||October 2012|
|Estimated Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
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.
Patients at normal risk of cancer
Patients found to have endoscopically and histological normal mucosa.
Patients who are under surveillance for known ulcerative colitis will be used to test those patients at higher risk of colorectal.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01075893
|Wansbeck General Hospital|
|Ashington, Tyne & Wear, United Kingdom, NE63 9JJ|
|North Tyneside Hospital|
|North Shields, Tyne & Wear, United Kingdom, NE29 8NH|
|Principal Investigator:||Iain JD McCallum, MBChB MRCS||Newcastle University, UK|
|Study Chair:||John C Mathers, PhD||Newcastle University, UK|
|Study Director:||Seamus B Kelly, MD FRCS||Newcastle University, UK|
|Study Director:||Mike Bradburn, MD FRCS||Northumbria NHS foundation trust|