Colorectal NeoplasmsNCT02047188
Observation of Microvessels and Invasion in Early Colorectal Lesions by NBI
An observational study of Colorectal Neoplasms, run by Xiaobo Li.
Trial summary
Combined with magnifying endoscopy,narrow-band imaging (NBI) contrasts microvascular architecture on lesion surface.The histology of early colorectal lesions could be predicted under NBI view.However,its capability for estimating invasion depth remains to be verified.The study is based on the hypothesis:NBI can… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colorectal Neoplasms
- How many people
- 418 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2013
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with early colorectal lesions
Who may be able to join
- patients of early colorectal lesions with capillary pattern(CP) type II\&III,initially detected by white-light view and then examined by NBI with magnifying endoscopy.
Who cannot join
- lesions with CP type I;
- CP type III lesions with an obvious appearance of advanced cancer;
- lesions that had underwent biopsy;
- patients with inflammatory bowel disease(IBD) or familial adenomatous polyposis(FAP)
- patients with previous colorectal surgery;
- having conditions associated with cardiac,hepatic,renal,and coagulopathy diseases.
About this study
Official title: Observation of Microvessels and Invasion in Early Colorectal Lesions by Narrow Band Imaging:Combination With Microvessel Count and MMP-7 Expression
Combined with magnifying endoscopy,narrow-band imaging (NBI) contrasts microvascular architecture on lesion surface.The histology of early colorectal lesions could be predicted under NBI view.However,its capability for estimating invasion depth remains to be verified.The study is based on the hypothesis:NBI can predict histology and invasion depth,combined with the verification of microvessel count and MMP-7 expression.
Read the detailed description
The microvessel count (MVC) is a classical method of assessing histologic grade.To verify whether NBI could predict histology through microvascular architecture,we measured lesion microvessels by immunohistochemistry.On the other hand,we applied immunohistochemistry of matrix metalloproteinase-7 (MMP-7) to validate the capability of NBI for estimating invasion depth.MMP-7 is directly involved in the processes of growth, invasion, and metastasis of colorectal cancer.Our target was to clarify the diagnostic accuracy of magnifying NBI in early colorectal lesions,combined with the verification of microvessel count and MMP-7 expression.
- Conditions
- Colorectal Neoplasms
- Keywords
- narrow band imaging,microvessels,matrix metalloproteinase-7
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
NBI prediction for lesion histology and invasion
We will receive the histologic findings in two weeks after lesion treatment.Then we can compare NBI prediction with the final histologic type.
Measured: in two weeks after lesion treatment
Secondary outcomes (1)
immunohistochemical outcome of microvessel count and MMP-7
We will receive the immunohistochemical outcome in three days after immunohistochemistry.Then we can compare NBI prediction with immunohistochemical outcome
Measured: in three days after immunohistochemistry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startJan 2010
- Primary completionMay 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiaobo Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaobo Li, Shanghai Jiao Tong University School of Medicine
- Investigators
- Xiaobo Li, Ph.D, Principal investigator, Shanghai Ren Ji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047188
- Sponsor's protocol ID
- 12YZ036
- Status last verified
- Jan 2014
- First submitted
- 25 Jan 2014
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Microvessels and Invasion in Early Colorectal Lesions by Narrow Band Imaging:Combination With Microvessel Count and MMP-7 Expression
- ClinicalTrials.gov ID
- NCT02047188
- Acronym / sponsor ID
- 12YZ036
- Conditions
- Colorectal Neoplasms
- Keywords
- narrow band imaging,microvessels,matrix metalloproteinase-7
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- Xiaobo LiUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Jan 2014 (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.
Combined with magnifying endoscopy,narrow-band imaging (NBI) contrasts microvascular architecture on lesion surface.The histology of early colorectal lesions could be predicted under NBI view.However,its capability for estimating invasion depth remains to be verified.The study is based on the hypothesis:NBI can predict histology and invasion depth,combined with the verification of microvessel count and MMP-7 expression.
Detailed description
The microvessel count (MVC) is a classical method of assessing histologic grade.To verify whether NBI could predict histology through microvascular architecture,we measured lesion microvessels by immunohistochemistry.On the other hand,we applied immunohistochemistry of matrix metalloproteinase-7 (MMP-7) to validate the capability of NBI for estimating invasion depth.MMP-7 is directly involved in the processes of growth, invasion, and metastasis of colorectal cancer.Our target was to clarify the diagnostic accuracy of magnifying NBI in early colorectal lesions,combined with the verification of microvessel count and MMP-7 expression.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with early colorectal lesions
Key inclusion criteria (1 listed)
- patients of early colorectal lesions with capillary pattern(CP) type II\&III,initially detected by white-light view and then examined by NBI with magnifying endoscopy.
Key exclusion criteria (6 listed)
- lesions with CP type I;
- CP type III lesions with an obvious appearance of advanced cancer;
- lesions that had underwent biopsy;
- patients with inflammatory bowel disease(IBD) or familial adenomatous polyposis(FAP)
- patients with previous colorectal surgery;
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
NBI prediction for lesion histology and invasion
Time frame: in two weeks after lesion treatment
We will receive the histologic findings in two weeks after lesion treatment.Then we can compare NBI prediction with the final histologic type.
1 secondary outcome
immunohistochemical outcome of microvessel count and MMP-7
Time frame: in three days after immunohistochemistry
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 28 Jan 2014.
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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.
Xiaobo Li, Ph.D principal investigator
Shanghai Ren Ji Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms, run by Xiaobo Li.
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 6 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 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
NBI prediction for lesion histology and invasion (time frame: in two weeks after lesion treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2014; AzTrials last refreshed its copy on 8 Nov 2026.