Skip to main content
OpenTrials
Completed

NCT Number: NCT01075893

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wansbeck General Hospital, Ashington, Tyne & Wear, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of stem cells in the colonic crypt

    Time frame: On day of endoscopy

Secondary outcomes

  1. Stem cell position in colonic crypt

    Time frame: On day of endoscopy

Sponsors and collaborators

Lead sponsor

Newcastle University

Other

Collaborators

  • Northumbria Healthcare NHS Foundation Trust

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 25, 2010
Registry last updated
Oct 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.