Gastric Intestinal MetaplasiaNCT01646528
The Value of Black Spots in Diagnosing Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy
An observational study of Gastric Intestinal Metaplasia, run by Shandong University at 1 site in China.
Trial summary
The study aims to: 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Intestinal Metaplasia
- What is being tested?
- CLE examination for upper gastrointestinal tract
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients without any disease of heart, liver or kidney.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Yanqing Li, MD, PhD, 86-531-82169236 ext. 82169508, liyanqing@sdu.edu.cn
About this study
Official title: The Value of Mesenchymal Black Spots in Diagnosing Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy
The study aims to:
- 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).
- Evaluate the incidences of gastric intraepithelial neoplasia and gastric cancer in patients with gastric mesenchymal black spot during CLE imaging.
Read the detailed description
Gastric intestinal metaplasia (GIM) is confirmed to be a risk factor that may lead to the development of intestinal type gastric cancer. Previous study has shown that confocal laser endomicroscopy promising in the diagnosis of GIM. The investigators have found an elevated incidence of mesenchymal black spots in patients with GIM during previous CLE imaging. This study aims to 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.
- Conditions
- Gastric Intestinal Metaplasia
- Being tested
- CLE examination for upper gastrointestinal tract
- Keywords
- Gastric Intestinal Metaplasia, Confocal Laser Endomicroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLE examination for upper gastrointestinal tractProcedure or surgery
Also called confocal endomicroscopy
Routine upper GI endoscopy plus targeted CLE examination
| Study group | Role | What they receive |
|---|---|---|
| Consecutive patients for CLE examination | Not described Receives: Procedure: CLE examination for upper gastrointestinal tract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of black spots in diagnosis of gastric intestinal metaplasia
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Intestinal MetaplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Yanqing Li, MD, PhD, Study director, Department of Gastroenterology, Qilu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01646528
- Sponsor's protocol ID
- 2012SDU-QILU-G01
- Status last verified
- Jul 2012
- First submitted
- 28 Jun 2012
- Last updated
- 20 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Mesenchymal Black Spots in Diagnosing Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy
- ClinicalTrials.gov ID
- NCT01646528
- Acronym / sponsor ID
- 2012SDU-QILU-G01
- Conditions
- Gastric Intestinal Metaplasia
- Keywords
- Gastric Intestinal Metaplasia, Confocal Laser Endomicroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to:
- 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).
- Evaluate the incidences of gastric intraepithelial neoplasia and gastric cancer in patients with gastric mesenchymal black spot during CLE imaging.
Detailed description
Gastric intestinal metaplasia (GIM) is confirmed to be a risk factor that may lead to the development of intestinal type gastric cancer. Previous study has shown that confocal laser endomicroscopy promising in the diagnosis of GIM. The investigators have found an elevated incidence of mesenchymal black spots in patients with GIM during previous CLE imaging. This study aims to 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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consecutive patients for CLE examination | – | Procedure: CLE examination for upper gastrointestinal tract |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients without any disease of heart, liver or kidney.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLE examination for upper gastrointestinal tractAlso: confocal endomicroscopyRoutine upper GI endoscopy plus targeted CLE examination | Procedure or surgery | Consecutive patients for CLE examination |
Primary outcome
Accuracy of black spots in diagnosis of gastric intestinal metaplasia
Time frame: up to six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanqing Li, MD, PhD study director
Department of Gastroenterology, Qilu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Intestinal Metaplasia, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanqing Li, MD, PhD (86-531-8216923 ext. 82169508, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of black spots in diagnosis of gastric intestinal metaplasia (time frame: up to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2012; AzTrials last refreshed its copy on 8 Nov 2026.