NCT01508520

Brief Summary

Magnifying endoscopy with narrow-band imaging (ME-NBI) can emphasize surface pattern and microvascular architecture of the gastric mucosa.However,the usefulness and criteria of NBI for differential diagnosis among early gastric cancers (EGC) have not been fully established.The study is based on the hypothesis:

  1. 1.ME-NBI is useful in distinguishing EGC from other gastric lesions
  2. 2.ME-NBI is useful in further differential diagnosis among EGCs.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 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

December 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2012

Completed
Last Updated

January 12, 2012

Status Verified

January 1, 2012

Enrollment Period

1.8 years

First QC Date

January 8, 2012

Last Update Submit

January 11, 2012

Conditions

Stomach Neoplasms

Keywords

early gastric cancerstomach neoplasmsmagnifying endoscopynarrow band imaging

Outcome Measures

Primary Outcomes (1)

  • diagnosis accuracy of ME-NBI

    ME-NBI diagnosis was made during real-time endoscopy procedure and reviewed in two weeks after ME-NBI examination. Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of ME-NBI diagnosis compared with histology were measured.

    in 2 weeks after ME-NBI examination

Eligibility Criteria

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

patients with gastric lesions suspected of early gastric malignancy

You may qualify if:

  • patients with gastric lesions which were detected by conventional screening endoscopy and suspected of early malignancy.

You may not qualify if:

  • advanced gastric cancer or any other malignancy;
  • patients under unsuitable conditions for examination or treatment, such as acute upper gastrointestinal bleeding, noncorrectable coagulopathy, severe systemic disease, etc;
  • inability to provide informed consent;
  • inability to provide histology of resected specimens after endoscopic treatment or surgery.

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

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Xiaobo Li, MD. 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 8, 2012

First Posted

January 12, 2012

Study Start

December 1, 2009

Primary Completion

October 1, 2011

Study Completion

December 1, 2011

Last Updated

January 12, 2012

Record last verified: 2012-01