Colorectal CancerNCT01075893
Changes in Stem Cells of the Colon in Response to Increased Risk of Colorectal Cancer
An observational study of Colorectal Cancer, run by Newcastle University at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- How many people
- 11 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Feb 2010to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Referred for endoscopy at participating centre
Who cannot join
- Age <16 or >85
- Familial polyposis syndrome
- Lynch syndrome
- Known colorectal tumour
- Previous colorectal resection
- Pregnancy
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Wansbeck General Hospital
Ashington, Tyne & Wear, NE63 9JJ
North Tyneside Hospital
North Shields, Tyne & Wear, NE29 8NH
About this study
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
- Colorectal Cancer
- Keywords
- Colorectal cancer, Stem cells, Ulcerative colitis, Polyps
- Medical subject headings
- Colorectal Neoplasms, Colitis, Ulcerative, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of stem cells in the colonic crypt
Measured: On day of endoscopy
Secondary outcomes (1)
Stem cell position in colonic crypt
Measured: On day of endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Collaborators
- Northumbria Healthcare NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Iain JD McCallum, MBChB MRCS, Principal investigator, Newcastle UniversityJohn C Mathers, PhD, Study chair, Newcastle UniversitySeamus B Kelly, MD FRCS, Study director, Newcastle UniversityMike Bradburn, MD FRCS, Study director, Northumbria NHS foundation trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075893
- Sponsor's protocol ID
- McCallum-001
- Status last verified
- Mar 2016
- First submitted
- 24 Feb 2010
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Dronamraju 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.
PubMed 18978177Barker 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.
PubMed 17934449
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Stem Cells of the Colon in Response to Increased Risk of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01075893
- Acronym / sponsor ID
- McCallum-001
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Stem cells, Ulcerative colitis, Polyps
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Collaborators
- Northumbria Healthcare NHS Foundation Trust
- Study start
- Feb 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 25 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Referred for endoscopy at participating centre
Key exclusion criteria (16 listed)
- Age <16 or >85
- Familial polyposis syndrome
- Lynch syndrome
- Known colorectal tumour
- Previous colorectal resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of stem cells in the colonic crypt
Time frame: On day of endoscopy
1 secondary outcome
Stem cell position in colonic crypt
Time frame: On day of endoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Background: PubMed 18978177Dronamraju 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.
- Background: PubMed 17934449Barker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iain JD McCallum, MBChB MRCS principal investigator
Newcastle University
John C Mathers, PhD study chair
Newcastle University
Seamus B Kelly, MD FRCS study director
Newcastle University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Newcastle University at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of stem cells in the colonic crypt (time frame: On day of endoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01075893, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2017.