- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02047188
Observation of Microvessels and Invasion in Early Colorectal Lesions by NBI
January 25, 2014 updated by: Xiaobo Li
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
418
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with early colorectal lesions
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
in two weeks after lesion treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
immunohistochemical outcome of microvessel count and MMP-7
Time Frame: in three days after immunohistochemistry
|
We will receive the immunohistochemical outcome in three days after immunohistochemistry.Then we can compare NBI prediction with immunohistochemical outcome
|
in three days after immunohistochemistry
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xiaobo Li, Ph.D, Shanghai Ren ji Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
January 25, 2014
First Submitted That Met QC Criteria
January 25, 2014
First Posted (Estimate)
January 28, 2014
Study Record Updates
Last Update Posted (Estimate)
January 28, 2014
Last Update Submitted That Met QC Criteria
January 25, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12YZ036
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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