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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Northumbria Healthcare NHS Foundation Trust
Information provided by (Responsible Party):
Newcastle University
ClinicalTrials.gov Identifier:
NCT01075893
First received: February 24, 2010
Last updated: October 25, 2011
Last verified: October 2011
History of Changes
  Purpose

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
Colorectal Cancer

Study Type: Observational
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Newcastle University:

Primary Outcome Measures:
  • Number of stem cells in the colonic crypt [ Time Frame: On day of endoscopy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 150
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)
Groups/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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01075893

Locations
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
Investigators
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

Publications:

Responsible Party: Newcastle University
ClinicalTrials.gov Identifier: NCT01075893     History of Changes
Other Study ID Numbers: McCallum-001
Study First Received: February 24, 2010
Last Updated: October 25, 2011
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 16, 2013