NCT02846688

Brief Summary

To analyze the genome pattern in human gastric Intestinal Metaplasia Mucosa and duodenal Mucosa.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

September 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
Last Updated

July 27, 2016

Status Verified

July 1, 2016

Enrollment Period

10 months

First QC Date

July 22, 2016

Last Update Submit

July 25, 2016

Conditions

Gene Expression ProfilingGastric Intestinal MetaplasiaDuodenum

Outcome Measures

Primary Outcomes (1)

  • Gene Expression Profiling in Human Gastric Intestinal Metaplasia Mucosa and Duodenal Mucosa

    6 months

Eligibility Criteria

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

Prospective patients scheduled for pCLE examination at Qilu Hospital, Shandong University

You may qualify if:

  • Patients scheduled for gastroendoscopy examination

You may not qualify if:

  • Esophageal, gastric or duodenal cancer or other malignancy History of upper GI tract surgery Coagulopathy or bleeding disorders Allergy to fluorescein sodium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

The metagenome was obtained from biopsy specimen.

Study Officials

  • li yanqing, PhD,MD

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gene Expression Profiling in Human Gastric Intestinal Metaplasia Mucosa and Duodenal Mucosa

Study Record Dates

First Submitted

July 22, 2016

First Posted

July 27, 2016

Study Start

September 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 27, 2016

Record last verified: 2016-07

Locations

CN(1)