Changes in Stem Cells of the Colon in Response to Increased Risk of Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Changes in Stem Cells of the Colon in Response to Increased Risk of Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01075893
• Other study ID #: McCallum-001
• Status: Completed
• Phase: N/A
• First received: February 24, 2010
• Last updated: October 27, 2017
• Start date: February 2010
• Est. completion date: October 2012

Study information

• Verified date: March 2016
• Source: Newcastle University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Referred for endoscopy at participating centre

Exclusion Criteria:

• Age <16 or >85

• 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
United Kingdom	Wansbeck General Hospital	Ashington	Tyne & Wear
United Kingdom	North Tyneside Hospital	North Shields	Tyne & Wear

Sponsors (2)

Lead Sponsor	Collaborator
Newcastle University	Northumbria Healthcare NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. Epub 2007 Oct 14. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of stem cells in the colonic crypt		On day of endoscopy
Secondary	Stem cell position in colonic crypt		On day of endoscopy