NCT01646528

Brief Summary

The study aims to:

  1. 1.Explore the properties of mesenchymal black spots, and to determine the value of mesenchymal black spots in diagnosing gastric intestinal metaplasia by confocal laser endomicroscopy (CLE).
  2. 2.Evaluate the incidences of gastric intraepithelial neoplasia and gastric cancer in patients with gastric mesenchymal black spot during CLE imaging.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 20, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 20, 2012

Status Verified

July 1, 2012

Enrollment Period

6 months

First QC Date

June 28, 2012

Last Update Submit

July 19, 2012

Conditions

Gastric Intestinal Metaplasia

Keywords

Gastric Intestinal MetaplasiaConfocal Laser Endomicroscopy

Outcome Measures

Primary Outcomes (1)

  • Accuracy of black spots in diagnosis of gastric intestinal metaplasia

    up to six months

Study Arms (1)

Consecutive patients for CLE examination

Procedure: CLE examination for upper gastrointestinal tract

Interventions

CLE examination for upper gastrointestinal tractPROCEDURE

Routine upper GI endoscopy plus targeted CLE examination

Also known as: confocal endomicroscopy
Consecutive patients for CLE examination

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients without any disease of heart, liver or kidney.

You may qualify if:

  • Patients will include male or female aged between 18 and 80 years with indications for upper-endoscopy , but without any disease of heart, liver or kidney.

You may not qualify if:

  • Patients who are allergic to fluorescein sodium
  • Patients who are unwilling to sign or give the informed consent form
  • Patients with impaired cardiac, liver or renal function
  • Patients with coagulopathy
  • Patients with pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Taken biopsies during endoscopy

Study Officials

  • Yanqing Li, MD, PhD

    Department of Gastroenterology, Qilu Hospital

    STUDY DIRECTOR

Central Study Contacts

Yanqing Li, MD, PhD

CONTACT

86-531-8216923liyanqing@sdu.edu.cn

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President, Chief of the Department of Gastroenterology, Qilu Hospital, Shandong University

Study Record Dates

First Submitted

June 28, 2012

First Posted

July 20, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 20, 2012

Record last verified: 2012-07

Locations

CN(1)