NCT02047188

Brief 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 predict histology and invasion depth,combined with the verification of microvessel count and MMP-7 expression.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
418

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
Last Updated

January 28, 2014

Status Verified

January 1, 2014

Enrollment Period

3.3 years

First QC Date

January 25, 2014

Last Update Submit

January 25, 2014

Conditions

Colorectal Neoplasms

Keywords

narrow band imaging,microvessels,matrix metalloproteinase-7

Outcome Measures

Primary Outcomes (1)

  • 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.

    in two weeks after lesion treatment

Secondary Outcomes (1)

  • immunohistochemical outcome of microvessel count and MMP-7

    in three days after immunohistochemistry

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with early colorectal lesions

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples after biopsy or resection are to be retained.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Xiaobo Li, Ph.D

    Shanghai Ren Ji Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Shanghai Institute of Digestive Disease，Renji Hospital, Shanghai Jiao Tong University School of Medicine

Study Record Dates

First Submitted

January 25, 2014

First Posted

January 28, 2014

Study Start

January 1, 2010

Primary Completion

May 1, 2013

Study Completion

December 1, 2013

Last Updated

January 28, 2014

Record last verified: 2014-01