Colorectal NeoplasmsNCT00623883
Colonoscopic Removal of Aberrant Crypt Foci: a Prospective, Randomized, Blinded Trial
A study testing Surgical removal of ACF and Colonoscopic evaluation only in people with Colorectal Neoplasms, run by National Naval Medical Center at 1 site in United States.
Trial summary
We hypothesized that aberrant crypt foci (ACF) are precursors of colon cancer; their prevention would correlate with cancer risk and their elimination would reduce that risk. In this study we wished to (1) establish the feasibility of stain-enhanced magnification colonoscopy, (2) determine whether colorectal cancer is… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Surgical removal of ACF and Colonoscopic evaluation only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1999to Jun 2007
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dept.of Defense Healthcare Beneficiaries
- Age 18 or over, non-pregnant
- History of colorectal cancer or other indication for colonoscopic screening
- At least half of large intestine remaining
- No use of investigational or chemotherapeutic drugs within 6 mos. -
Who cannot join
- History suggesting familial colon cancer syndrome
- < 6 mos since colon resection or since treatment for colon cancer
- Anticipated colon surgery within one year of entry
- Inability to participate in scheduled followup at one year
- Medical or psychiatric condition which would make patient a poor candidate -
Trial locations and contacts
1 site in 1 country.
United States1 site
National Naval Medical Center
Bethesda, Maryland, 20889
About this study
Official title: Colonoscopic Biomarkers for Cancer Risk Assessment and Prevention
We hypothesized that aberrant crypt foci (ACF) are precursors of colon cancer; their prevention would correlate with cancer risk and their elimination would reduce that risk. In this study we wished to (1) establish the feasibility of stain-enhanced magnification colonoscopy, (2) determine whether colorectal cancer is asociated with increased numbers of ACF, and (3) investigate the natural history of ACF and the durability of their elimination.
Read the detailed description
Subjects are randomly assigned at the time of stain-enhanced magnification colonoscopy to have any ACF removed or merely observed. Subjects are evenly divided into those with and those without a personal history of colon cancer. ACF are tabulated by an observer blinded to the subject's personal history. All subjects are then re-evaluated after one year by an observer blinded to the original procedure.
- Conditions
- Colorectal Neoplasms
- Being tested
- Surgical removal of ACF, Colonoscopic evaluation only
- Keywords
- Human Colonic Aberrant Crypt Foci
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical removal of ACFProcedure or surgery
All ACF removed by either cold or hot colonoscopic biopsy forceps
Colonoscopic evaluation onlyProcedure or surgery
Stain-enhanced magnification endoscopy performed, ACF quantified at entry and after one year
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All identified ACF eliminated by cold or hot colonoscopic biopsy forceps Receives: Procedure: Surgical removal of ACF |
| 2 | Sham comparator | ACF quantified and observed, re-evaluated after one year Receives: Procedure: Colonoscopic evaluation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
number, size, and location of ACF identified
Measured: initially and after one year
Secondary outcomes (1)
complications of stain-enhanced, magnification colonoscopy
Measured: initially and after one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startJan 1999
- Primary completionJun 2007
- Study completionJun 2007
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 NeoplasmsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Naval Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Uniformed Services University of the Health Sciences, National Cancer Institute (NCI)
- Investigators
- Peter W. Soballe, M.D., Principal investigator, National Naval Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623883
- Sponsor's protocol ID
- NNMC.1997.0091
- Status last verified
- Jun 2007
- First submitted
- 15 Feb 2008
- Last updated
- 26 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Glebov OK, Rodriguez LM, Soballe P, DeNobile J, Cliatt J, Nakahara K, Kirsch IR. Gene expression patterns distinguish colonoscopically isolated human aberrant crypt foci from normal colonic mucosa. Cancer Epidemiol Biomarkers Prev. 2006 Nov;15(11):2253-62. doi: 10.1158/1055-9965.EPI-05-0694.
PubMed 17119054Glebov OK, Rodriguez LM, Nakahara K, Jenkins J, Cliatt J, Humbyrd CJ, DeNobile J, Soballe P, Simon R, Wright G, Lynch P, Patterson S, Lynch H, Gallinger S, Buchbinder A, Gordon G, Hawk E, Kirsch IR. Distinguishing right from left colon by the pattern of gene expression. Cancer Epidemiol Biomarkers Prev. 2003 Aug;12(8):755-62.
PubMed 12917207
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonoscopic Biomarkers for Cancer Risk Assessment and Prevention
- ClinicalTrials.gov ID
- NCT00623883
- Acronym / sponsor ID
- NNMC.1997.0091
- Conditions
- Colorectal Neoplasms
- Keywords
- Human Colonic Aberrant Crypt Foci
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- National Naval Medical CenterUS federal agency
- Collaborators
- Uniformed Services University of the Health Sciences, National Cancer Institute (NCI)
- Study start
- Jan 1999
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 26 Feb 2008 (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.
We hypothesized that aberrant crypt foci (ACF) are precursors of colon cancer; their prevention would correlate with cancer risk and their elimination would reduce that risk. In this study we wished to (1) establish the feasibility of stain-enhanced magnification colonoscopy, (2) determine whether colorectal cancer is asociated with increased numbers of ACF, and (3) investigate the natural history of ACF and the durability of their elimination.
Detailed description
Subjects are randomly assigned at the time of stain-enhanced magnification colonoscopy to have any ACF removed or merely observed. Subjects are evenly divided into those with and those without a personal history of colon cancer. ACF are tabulated by an observer blinded to the subject's personal history. All subjects are then re-evaluated after one year by an observer blinded to the original procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Surgical removal of ACFAll identified ACF eliminated by cold or hot colonoscopic biopsy forceps |
| 2 | Sham comparator | Procedure: Colonoscopic evaluation onlyACF quantified and observed, re-evaluated after one year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Dept.of Defense Healthcare Beneficiaries
- Age 18 or over, non-pregnant
- History of colorectal cancer or other indication for colonoscopic screening
- At least half of large intestine remaining
- No use of investigational or chemotherapeutic drugs within 6 mos. -
Key exclusion criteria (5 listed)
- History suggesting familial colon cancer syndrome
- < 6 mos since colon resection or since treatment for colon cancer
- Anticipated colon surgery within one year of entry
- Inability to participate in scheduled followup at one year
- Medical or psychiatric condition which would make patient a poor candidate -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical removal of ACFAll ACF removed by either cold or hot colonoscopic biopsy forceps | Procedure or surgery | 1 |
| Colonoscopic evaluation onlyStain-enhanced magnification endoscopy performed, ACF quantified at entry and after one year | Procedure or surgery | 2 |
Primary outcome
number, size, and location of ACF identified
Time frame: initially and after one year
1 secondary outcome
complications of stain-enhanced, magnification colonoscopy
Time frame: initially and after one year
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 26 Feb 2008.
- Results publication: PubMed 17119054Glebov OK, Rodriguez LM, Soballe P, DeNobile J, Cliatt J, Nakahara K, Kirsch IR. Gene expression patterns distinguish colonoscopically isolated human aberrant crypt foci from normal colonic mucosa. Cancer Epidemiol Biomarkers Prev. 2006 Nov;15(11):2253-62. doi: 10.1158/1055-9965.EPI-05-0694.
- Results publication: PubMed 12917207Glebov OK, Rodriguez LM, Nakahara K, Jenkins J, Cliatt J, Humbyrd CJ, DeNobile J, Soballe P, Simon R, Wright G, Lynch P, Patterson S, Lynch H, Gallinger S, Buchbinder A, Gordon G, Hawk E, Kirsch IR. Distinguishing right from left colon by the pattern of gene expression. Cancer Epidemiol Biomarkers Prev. 2003 Aug;12(8):755-62.
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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.
Peter W. Soballe, M.D. principal investigator
National Naval Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical removal of ACF and Colonoscopic evaluation only in people with Colorectal Neoplasms, run by National Naval Medical Center at 1 site in United States.
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 5 inclusion and 5 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 26 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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, size, and location of ACF identified (time frame: initially and after one year). 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 NCT00623883, 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 26 Feb 2008.