Clinical trial · Observational
Changes in Stem Cells of the Colon in Response to Increased Risk of Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Adenomatous polyp
- description
- 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.
- label
- Patients at normal risk of cancer
- description
- Patients found to have endoscopically and histological normal mucosa.
- label
- Ulcerative colitis
- description
- Patients who are under surveillance for known ulcerative colitis will be used to test those patients at higher risk of colorectal.
Primary outcomes (1)
- measure
- Number of stem cells in the colonic crypt
- timeFrame
- On day of endoscopy
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDDronamraju SS, Coxhead JM, Kelly SB, Burn J, Mathers JC. Cell kinetics and gene expression changes in colorectal cancer patients given resistant starch: a randomised controlled trial. Gut. 2009 Mar;58(3):413-20. doi: 10.1136/gut.2008.162933. Epub 2008 Oct 31. PMID 18978177
- BACKGROUNDBarker N, van Es JH, Kuipers J, Kujala P, van den Born M, Cozijnsen M, Haegebarth A, Korving J, Begthel H, Peters PJ, Clevers H. Identification of stem cells in small intestine and colon by marker gene Lgr5. Nature. 2007 Oct 25;449(7165):1003-7. doi: 10.1038/nature06196. Epub 2007 Oct 14. PMID 17934449