Gene Expression ProfilingNCT02846688
Gene Expression Profiling in Human Gastric Intestinal Metaplasia Mucosa and Duodenal Mucosa
An observational study of Gene Expression Profiling and Gastric Intestinal Metaplasia, run by Shandong University at 1 site in China.
Trial summary
To analyze the genome pattern in human gastric Intestinal Metaplasia Mucosa and duodenal Mucosa. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gene Expression Profiling, Gastric Intestinal Metaplasia, Duodenum
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Jul 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Prospective patients scheduled for pCLE examination at Qilu Hospital, Shandong University
Who may be able to join
- Patients scheduled for gastroendoscopy examination
Who cannot join
- Esophageal, gastric or duodenal cancer or other malignancy History of upper GI tract surgery Coagulopathy or bleeding disorders Allergy to fluorescein sodium
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
About this study
Official title: Gene Expression Profiling in Human Gastric Intestinal Metaplasia Mucosa and Duodenal Mucosa.
To analyze the genome pattern in human gastric Intestinal Metaplasia Mucosa and duodenal Mucosa.
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene Expression Profiling in Human Gastric Intestinal Metaplasia Mucosa and Duodenal Mucosa
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startSep 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gene Expression ProfilingStudies 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- li yanqing, PhD,MD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846688
- Sponsor's protocol ID
- 2015SDU-QILU-G05
- Status last verified
- Jul 2016
- First submitted
- 22 Jul 2016
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression Profiling in Human Gastric Intestinal Metaplasia Mucosa and Duodenal Mucosa.
- ClinicalTrials.gov ID
- NCT02846688
- Acronym / sponsor ID
- 2015SDU-QILU-G05
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 27 Jul 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.
To analyze the genome pattern in human gastric Intestinal Metaplasia Mucosa and duodenal Mucosa.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective patients scheduled for pCLE examination at Qilu Hospital, Shandong University
Key inclusion criteria (1 listed)
- Patients scheduled for gastroendoscopy examination
Key exclusion criteria (1 listed)
- Esophageal, gastric or duodenal cancer or other malignancy History of upper GI tract surgery Coagulopathy or bleeding disorders Allergy to fluorescein sodium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gene Expression Profiling in Human Gastric Intestinal Metaplasia Mucosa and Duodenal Mucosa
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
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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, PhD,MD 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?
An observational study of Gene Expression Profiling and 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 1 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: finished, as of the sponsor's last update on 27 Jul 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene Expression Profiling in Human Gastric Intestinal Metaplasia Mucosa and Duodenal Mucosa (time frame: 6 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 27 Jul 2016.