This trial is active, not recruiting.

Condition colorectal cancer
Sponsor Newcastle University
Collaborator Northumbria Healthcare NHS Foundation Trust
Start date February 2010
End date October 2012
Trial size 150 participants
Trial identifier NCT01075893, McCallum-001


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
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 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.

Primary Outcomes

Number of stem cells in the colonic crypt
time frame: On day of endoscopy

Secondary Outcomes

Stem cell position in colonic crypt
time frame: On day of endoscopy

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title Changes in Stem Cells of the Colon in Response to Increased Risk of Colorectal Cancer
Principal investigator Iain JD McCallum, MBChB MRCS
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by Newcastle University.