NCT02932735

Brief Summary

Gastric intestinal metaplasia (GIM) is an important premalignant lesion for gastric cancer. Precisely surveillance of patients with GIM may result in early detection and improved prognosis. Though important, it is not necessary to recommend surveillance endoscopy for all patients with GIM, since the progression rate to gastric cancer within 10 years is only 1.8% in those patients.

Trial Health

35
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 Oct 2016

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

8 months

First QC Date

October 10, 2016

Last Update Submit

October 12, 2016

Conditions

Probe-based Confocal Laser Endomicroscopythe Operative Link on Gastric Intestinal Metaplasia

Outcome Measures

Primary Outcomes (2)

  • the sensitivity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM).

    6 months

  • the of specificity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM).

    6 months

Secondary Outcomes (2)

  • the of sensitivity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging Gastric Intestinal Metaplasia (GIM).

    6 months

  • the of specificity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging Gastric Intestinal Metaplasia (GIM).

    6 months

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients scheduled for pCLE examination will be recruited in this study at Qilu Hospital, Shandong University.

You may qualify if:

  • Patients aged 40 years or older with Helicobacter pylori infection;
  • Histologically verified GIM, atrophic gastritis or dysplasia.

You may not qualify if:

  • Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
  • Conditions unsuitable for performance of pCLE, such as coagulopathy, impaired renal function or allergy to fluorescein sodium;
  • Pregnancy or breastfeeding;
  • Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Li Yanqing, MD, PhD

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Yanqing, MD, PhD

CONTACT

86-531-82169236liyanqing@sdu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Qilu Hospital

Study Record Dates

First Submitted

October 10, 2016

First Posted

October 13, 2016

Study Start

October 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

October 13, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share