Colorectal NeoplasmsNCT00586053
Unprepped CT Colonography
An observational study of Colorectal Neoplasms, run by Mayo Clinic at 1 site in United States.
Trial summary
It is our objective to improve the performance of CTC in the prepared colon, and to validate CTC in the unprepared colon for the detection of colorectal neoplasia. The cost-effectiveness ratio of CTC in the unprepared colon will compare favorably with other colorectal screening test. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms
- How many people
- 1,255 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2000to Dec 2009
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Mayo Clinic patients scheduled for colonoscopy.
Who may be able to join
- Average risk or higher for colorectal cancer and scheduled for colonoscopy with any of the following indications:
- Prior colorectal cancer, prior colorectal adenoma, strong family history of colorectal neoplasia, iron deficiency.
- Age ≥ 40 -100 years
- Known or highly suspected primary colorectal neoplasms > 10 mm (n = 160)
- Higher than average risk for colorectal cancer and scheduled for colonoscopy with any of the following indications: prior colorectal cancer, prior colorectal adenoma, strong family history of colorectal neoplasia, iron deficiency.
Who cannot join
- Less than 1/2 of colorectum remaining
- Inflammatory bowel disease (Crohns, Chronic Ulcerative Colitis)
- Familial Polyposis
- Melena, hematochezia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "CTC of the Unprepped Colon: Optimization & Validation"
It is our objective to improve the performance of CTC in the prepared colon, and to validate CTC in the unprepared colon for the detection of colorectal neoplasia. The cost-effectiveness ratio of CTC in the unprepared colon will compare favorably with other colorectal screening test.
Read the detailed description
To improve the diagnostic performance of CTC in the prepared colon using improved spatial resolution, advanced image displays, and computer-assisted diagnosis, and to optimize diagnostic performance of CTC in the unprepared colon for colorectal polyp detection using electronic stool subtraction and computer-aided diagnostic techniques. To estimate the sensitivity and specificity of CTC in the unprepared colon for clinically important colorectal neoplasms (large adenomas ≥ 1 cm) and to compare such estimates with colonoscopy. To survey patient acceptance of CTC in the unprepared colon, and to assess implications for health care costs and cost-effectiveness of CTC in the unprepared colon in comparison with other approaches.
- Conditions
- Colorectal Neoplasms
- Keywords
- Colonic Polyps, Colon, Large Intestine, Cecum, Sigmoid, Rectum, Colonoscopy, Virtual Colonoscopy, CT Colonography, Computed Tomographic Colonography, Colonography
- Medical subject headings
- Colorectal Neoplasms, Colonic 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 |
|---|---|---|
| 1 | 485 patients,who have an average risk (asymptomatic and without colon screening in the last 5 years) or those who have a high risk for colon cancer (strong family history of colon cancer or polyps and/or personal history of colon cancer or polyps). | |
| 2 | 160 patients, with a known colorectal lesion at or greater than 1 cm. | |
| 3 | 610 patients, who are of average risk for colon cancer (asymptomatic and no colon cancer screening in the last 5 years). |
What is being measured
The primary outcome is the main question the study is designed to answer.
To optimize diagnostic performance of CTC in the unprepared colon for colorectal polyp detection using electronic stool subtraction and computer-aided diagnostic techniques.
Measured: 2000-2009
Secondary outcomes (1)
The cost-effectiveness ratio of CTC in the unprepared colon will compare favorably with other colorectal screening tests
Measured: 2000-2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startAug 2000
- Primary completionDec 2008
- Study completionDec 2009
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.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- C. Daniel Johnson, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586053
- Sponsor's protocol ID
- 1221-00
- Other IDs
- CA75333-08
- Status last verified
- Feb 2010
- First submitted
- 21 Dec 2007
- Last updated
- 11 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
MacCarty RL, Johnson CD, Fletcher JG, Wilson LA. Occult colorectal polyps on CT colonography: implications for surveillance. AJR Am J Roentgenol. 2006 May;186(5):1380-3. doi: 10.2214/AJR.05.0031.
PubMed 16632734Johnson CD, Fletcher JG, MacCarty RL, Mandrekar JN, Harmsen WS, Limburg PJ, Wilson LA. Effect of slice thickness and primary 2D versus 3D virtual dissection on colorectal lesion detection at CT colonography in 452 asymptomatic adults. AJR Am J Roentgenol. 2007 Sep;189(3):672-80. doi: 10.2214/AJR.07.2354.
PubMed 17715116
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "CTC of the Unprepped Colon: Optimization & Validation"
- ClinicalTrials.gov ID
- NCT00586053
- Acronym / sponsor ID
- 1221-00
- Conditions
- Colorectal Neoplasms
- Keywords
- Colonic Polyps, Colon, Large Intestine, Cecum, Sigmoid, Rectum, Colonoscopy, Virtual Colonoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,255 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Aug 2000
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 4 Jan 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.
It is our objective to improve the performance of CTC in the prepared colon, and to validate CTC in the unprepared colon for the detection of colorectal neoplasia. The cost-effectiveness ratio of CTC in the unprepared colon will compare favorably with other colorectal screening test.
Detailed description
To improve the diagnostic performance of CTC in the prepared colon using improved spatial resolution, advanced image displays, and computer-assisted diagnosis, and to optimize diagnostic performance of CTC in the unprepared colon for colorectal polyp detection using electronic stool subtraction and computer-aided diagnostic techniques. To estimate the sensitivity and specificity of CTC in the unprepared colon for clinically important colorectal neoplasms (large adenomas ≥ 1 cm) and to compare such estimates with colonoscopy. To survey patient acceptance of CTC in the unprepared colon, and to assess implications for health care costs and cost-effectiveness of CTC in the unprepared colon in comparison with other approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –485 patients,who have an average risk (asymptomatic and without colon screening in the last 5 years) or those who have a high risk for colon cancer (strong family history of colon cancer or polyps and/or personal history of colon cancer or polyps). |
| 2 | – | –160 patients, with a known colorectal lesion at or greater than 1 cm. |
| 3 | – | –610 patients, who are of average risk for colon cancer (asymptomatic and no colon cancer screening in the last 5 years). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Mayo Clinic patients scheduled for colonoscopy.
Key inclusion criteria (5 listed)
- Average risk or higher for colorectal cancer and scheduled for colonoscopy with any of the following indications:
- Prior colorectal cancer, prior colorectal adenoma, strong family history of colorectal neoplasia, iron deficiency.
- Age ≥ 40 -100 years
- Known or highly suspected primary colorectal neoplasms > 10 mm (n = 160)
- Higher than average risk for colorectal cancer and scheduled for colonoscopy with any of the following indications: prior colorectal cancer, prior colorectal adenoma, strong family history of colorectal neoplasia, iron deficiency.
Key exclusion criteria (4 listed)
- Less than 1/2 of colorectum remaining
- Inflammatory bowel disease (Crohns, Chronic Ulcerative Colitis)
- Familial Polyposis
- Melena, hematochezia
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
To optimize diagnostic performance of CTC in the unprepared colon for colorectal polyp detection using electronic stool subtraction and computer-aided diagnostic techniques.
Time frame: 2000-2009
1 secondary outcome
The cost-effectiveness ratio of CTC in the unprepared colon will compare favorably with other colorectal screening tests
Time frame: 2000-2009
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 11 Feb 2010.
- Results publication: PubMed 16632734MacCarty RL, Johnson CD, Fletcher JG, Wilson LA. Occult colorectal polyps on CT colonography: implications for surveillance. AJR Am J Roentgenol. 2006 May;186(5):1380-3. doi: 10.2214/AJR.05.0031.
- Results publication: PubMed 17715116Johnson CD, Fletcher JG, MacCarty RL, Mandrekar JN, Harmsen WS, Limburg PJ, Wilson LA. Effect of slice thickness and primary 2D versus 3D virtual dissection on colorectal lesion detection at CT colonography in 452 asymptomatic adults. AJR Am J Roentgenol. 2007 Sep;189(3):672-80. doi: 10.2214/AJR.07.2354.
Related trials for Colorectal Neoplasms
Recruiting
MRD Monitoring in Colorectal Cancer Using ctDNA
Colorectal Neoplasms, Colorectal Cancer (Diagnosis)
Recruiting
Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
Ampulla of Vater Carcinoma, Appendix Carcinoma
Not yet recruitingPhase 2/3
Master Protocol for the Study of Rilogrotug for the Treatment of Weight Loss and Anorexia in Patients With Cancer Cachexia and mCRC or mNSCLC
Cachexia; Cancer, Cachexia
Active, not recruitingPhase 3
Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Colon Adenocarcinoma, DNA Repair Disorder
Not yet recruitingPhase 2
Combining DCSZ11 With Radiation and Chemotherapy as Neoadjuvant Treatment for pMMR Locally Advanced Rectal Cancer
Rectal Cancer
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.
C. Daniel Johnson, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms, run by Mayo Clinic 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 4 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 11 Feb 2010. 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. 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?
To optimize diagnostic performance of CTC in the unprepared colon for colorectal polyp detection using electronic stool subtraction and computer-aided diagnostic techniques. (time frame: 2000-2009). 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 NCT00586053, 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 11 Feb 2010.