We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01075893
Recruitment Status : Completed
First Posted : February 25, 2010
Last Update Posted : October 31, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Colorectal Cancer

Study Design

Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Changes in Stem Cells of the Colon in Response to Increased Risk of Colorectal Cancer
Study Start Date : February 2010
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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.
Patients at normal risk of cancer
Patients found to have endoscopically and histological normal mucosa.
Ulcerative colitis
Patients who are under surveillance for known ulcerative colitis will be used to test those patients at higher risk of colorectal.

Outcome Measures

Primary Outcome Measures :
  1. Number of stem cells in the colonic crypt [ Time Frame: On day of endoscopy ]

Secondary Outcome Measures :
  1. Stem cell position in colonic crypt [ Time Frame: On day of endoscopy ]

Biospecimen Retention:   Samples Without DNA
Rectal pinch biopsies - x 9 (10 cm from anal verge)

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients referred for lower gastrointestinal (GI) endoscopy at a participating centre will be considered for inclusion. Patients with a previous adenomatous polyp resection under surveillance will be considered for inclusion to the polyp group. Patients with ulcerative colitis under surveillance will be considered for inclusion to the ulcerative colitis group.

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075893

United Kingdom
Wansbeck General Hospital
Ashington, Tyne & Wear, United Kingdom, NE63 9JJ
North Tyneside Hospital
North Shields, Tyne & Wear, United Kingdom, NE29 8NH
Sponsors and Collaborators
Newcastle University
Northumbria Healthcare NHS Foundation Trust
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
More Information

Responsible Party: Newcastle University
ClinicalTrials.gov Identifier: NCT01075893     History of Changes
Other Study ID Numbers: McCallum-001
First Posted: February 25, 2010    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: March 2016

Keywords provided by Newcastle University:
Colorectal cancer
Stem cells
Ulcerative colitis

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases