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

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ClinicalTrials.gov Identifier: NCT01075893
Recruitment Status : Completed
First Posted : February 25, 2010
Last Update Posted : October 31, 2017
Sponsor:
Collaborator:
Northumbria Healthcare NHS Foundation Trust
Information provided by (Responsible Party):
Newcastle University

Tracking Information
First Submitted Date February 24, 2010
First Posted Date February 25, 2010
Last Update Posted Date October 31, 2017
Study Start Date February 2010
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 24, 2010)
Number of stem cells in the colonic crypt [ Time Frame: On day of endoscopy ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01075893 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 24, 2010)
Stem cell position in colonic crypt [ Time Frame: On day of endoscopy ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Changes in Stem Cells of the Colon in Response to Increased Risk of Colorectal Cancer
Official Title Changes in Stem Cells of the Colon in Response to Increased Risk of Colorectal Cancer
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Rectal pinch biopsies - x 9 (10 cm from anal verge)
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.
Condition Colorectal Cancer
Intervention Not Provided
Study 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 27, 2017)
11
Original Estimated Enrollment
 (submitted: February 24, 2010)
150
Actual Study Completion Date October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01075893
Other Study ID Numbers McCallum-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Newcastle University
Study Sponsor Newcastle University
Collaborators 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
PRS Account Newcastle University
Verification Date March 2016