Gastric Intestinal MetaplasiaPhase 4NCT02930616
A Comparison of pCLE Based Targeted Biopsy and WLE Based Standard Biopsy in Staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM): A Randomized，Cross-over Study
A Phase 4 study testing Patients in Group 1 will receive pCLE at first and WLE 2 months later and patients in Group 2 will receive WLE at first and pCLE 2 months later. in people with Gastric Intestinal Metaplasia and Confocal Laser Endomicroscopy, run by Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Gastric Intestinal Metaplasia, Confocal Laser Endomicroscopy, Operative Link on Gastric Intestinal Metaplasia
- What is being tested?
- Patients in Group 1 will receive pCLE at first and WLE 2 months later and patients in Group 2 will receive WLE at first and pCLE 2 months later.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Jun 2017
- Phase
- Phase 4
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 40 years or older with Helicobacter pylori infection;
- Histologically verified GIM, atrophic gastritis or dysplasia.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Yanqing Li, MD, PhD, 86-531-82169236, liyanqing@sdu.edu.cn
Yanqing Li, MD, PhD, 86-0531-82169236, liyanqing@sdu.edu.cn
About this study
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.
- Conditions
- Gastric Intestinal Metaplasia, Confocal Laser Endomicroscopy, Operative Link on Gastric Intestinal Metaplasia, Biopsy
- Being tested
- Patients in Group 1 will receive pCLE at first and WLE 2 months later, patients in Group 2 will receive WLE at first and pCLE 2 months later.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients in Group 1 will receive pCLE at first and WLE 2 months laterDevice
patients in Group 2 will receive WLE at first and pCLE 2 months later.Device
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | Patients in Group 1 will receive probe-based confocal endomicroscopy (pCLE) at first and Wight light endoscopy (WLE) 2 months later Receives: Device: Patients in Group 1 will receive pCLE at first and WLE 2 months later |
| goup 2 | Active comparator | patients in Group 2 will receive WLE at first and pCLE 2 months later. Receives: Device: patients in Group 2 will receive WLE at first and pCLE 2 months later. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by pCLE.
Measured: 9 months
the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by WLE.
Measured: 9 months
Secondary outcomes (2)
the overall detection rate of GIM by pCLE.
Measured: 9 months
the overall detection rate of GIM by WLE.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Li Yanqing, MD, PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930616
- Sponsor's protocol ID
- 2016SDU-QILU-17
- Status last verified
- Oct 2016
- First submitted
- 10 Oct 2016
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of pCLE Based Targeted Biopsy and WLE Based Standard Biopsy in Staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM): A Randomized，Cross-over Study
- ClinicalTrials.gov ID
- NCT02930616
- Acronym / sponsor ID
- 2016SDU-QILU-17
- Conditions
- Gastric Intestinal Metaplasia, Confocal Laser Endomicroscopy, Operative Link on Gastric Intestinal Metaplasia, Biopsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 12 Oct 2016 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Device: Patients in Group 1 will receive pCLE at first and WLE 2 months laterPatients in Group 1 will receive probe-based confocal endomicroscopy (pCLE) at first and Wight light endoscopy (WLE) 2 months later |
| goup 2 | Active comparator | Device: patients in Group 2 will receive WLE at first and pCLE 2 months later.patients in Group 2 will receive WLE at first and pCLE 2 months later. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 40 years or older with Helicobacter pylori infection;
- Histologically verified GIM, atrophic gastritis or dysplasia.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Patients in Group 1 will receive pCLE at first and WLE 2 months later | Device | group 1 |
| patients in Group 2 will receive WLE at first and pCLE 2 months later. | Device | goup 2 |
Primary outcome
the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by pCLE.
Time frame: 9 months
the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by WLE.
Time frame: 9 months
2 secondary outcomes
the overall detection rate of GIM by pCLE.
Time frame: 9 months
the overall detection rate of GIM by WLE.
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Li Yanqing, MD, PhD principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Patients in Group 1 will receive pCLE at first and WLE 2 months later and patients in Group 2 will receive WLE at first and pCLE 2 months later. in people with Gastric Intestinal Metaplasia and Confocal Laser Endomicroscopy, 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 2 inclusion and 4 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 12 Oct 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Li Yanqing, MD, PhD (86-531-82169236, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by pCLE. (time frame: 9 months). The study lists 2 primary outcomes in all. 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 12 Oct 2016.