NCT01431703

Brief Summary

It exists a learning curve in using NBI with magnification to differentiating colorectal lesions.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
326

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Shorter than P25 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

May 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2011

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

March 1, 2017

Completed
Last Updated

March 1, 2017

Status Verified

January 1, 2017

Enrollment Period

11 months

First QC Date

September 8, 2011

Results QC Date

April 26, 2016

Last Update Submit

January 8, 2017

Conditions

Keywords

narrow band imaginglearning curvecolorectaldifferential diagnosiswith colorectal lesionNBI with magnification

Outcome Measures

Primary Outcomes (1)

  • Accuracy, Sensitivity, and Specificity for Differentiating Neoplastic and Non-neoplastic Lesions

    For this training, patients were consecutively enrolled until a total of 45 target and non-target lesions were obtained.

Eligibility Criteria

Age16 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

academic hospital endoscopist of digestive department

You may qualify if:

  • Ages 16 to 85
  • Any patient undergoing NBI with magnification colonoscopy exam and found with colorectal lesions

You may not qualify if:

  • Unwilling to consent
  • Had surgery of colorectal tumors
  • Using NSAIDS
  • Diagnosed or suspected IBD
  • Familial adenomatous polyposis(FAP) or hereditary non-polyposis colorectal(HNPCC) or other hereditary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

if the lesion is neoplastic or sm deeper cancer, we just take biopsy.If the lesion is adenomatous or sm1-2 cancer,we do polypectomy, EMR or ESD to get the specimen.

Results Point of Contact

Title
Dr Ge zhi zheng
Organization
Shanghai Jiaotong university

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
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

September 8, 2011

First Posted

September 9, 2011

Study Start

May 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

March 1, 2017

Results First Posted

March 1, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share