NCT01521104

Brief Summary

Magnification narrow band imaging (NBI) can make accurate evaluation in in predicting of invasive depth of colorectal neoplasia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
565

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

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, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 30, 2012

Completed
Last Updated

January 30, 2012

Status Verified

January 1, 2012

Enrollment Period

1.9 years

First QC Date

January 25, 2012

Last Update Submit

January 27, 2012

Conditions

Colorectal Neoplasms

Keywords

narrow band imaging（NBI）colorectal lesionspredicting histology

Eligibility Criteria

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

consecutive adult patients undergo colonoscopy and find out more than one lesion ≧ 6mm from Jan 2009 to Dec 2010

You may qualify if:

  • Consecutive patients with more than one lesion ≧6mm

You may not qualify if:

  • Patients with chronic inflammatory bowel disease,
  • advanced cancer,
  • insufficient bowel preparation,
  • familial adenomatous polyposis (FAP)
  • Lesions ≦ 5mm and submucosal tumor (SMT).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

All the lesions will be removed endoscopically or surgically and examined histologically by an independent gastrointestinal pathologist. Histological diagnosis is determined according to the World Health Organization (WHO) criteria.Pedunculated lesions are categorized according to Haggitt's classification.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

January 25, 2012

First Posted

January 30, 2012

Study Start

January 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 30, 2012

Record last verified: 2012-01