Gastric NeoplasiaNCT02863965
High Definition Endoscopy and Optic Enhancement Endoscopy in Gastric Neoplasia: A Prospective Study
An observational study of Gastric Neoplasia, run by Shandong University at 1 site in China.
Trial summary
The aim of the study is to evaluate the diagnostic value of high definition endoscopy and optic enhancement in gastric neoplasia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Neoplasia
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Oct 2016
- 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 with dyspeptic symptoms and aged 40 years or older, or with Helicobacter pylori infection, histologically verified gastric intestinal metaplasia or atrophic gastritis, or with family history of gastric cancer
Who may be able to join
- patients with dyspeptic symptoms and aged 40 years or older
- or patients with Helicobacter pylori infection, or histologically verified gastric intestinal metaplasia or atrophic gastritis
- or patients with family history of gastric cancer
Who cannot join
- presence of gastrectomy, acute gastrointestinal bleeding, or known gastric neoplasia
- presence of conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding
- inability to provide informed consent
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, PhD. MD., 18678827666, liyanqing@sdu.edu.cn
About this study
The aim of the study is to evaluate the diagnostic value of high definition endoscopy and optic enhancement in gastric neoplasia.
- Conditions
- Gastric Neoplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High definition endoscopy and optic enhancement | All the patients underwent routine preparation before the procedure. The detected lesions in high definition endoscopy were observed with optic enhancement mode. The endoscopist was required to give the real-time descriptions of surface pit patterns of the lesions, based on surface pattern classification. After that, biopsy specimens will be obtained respectively by forceps from each detected lesion recorded for histologic diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of optical enhancement endoscopy in diagnosis of gastric neoplasia
Measured: 8 months
Specificity of optical enhancement endoscopy in diagnosis of gastric neoplasia
Measured: 8 months
Positive predictive value of optical enhancement endoscopy in diagnosis of gastric neoplasia
Measured: 8 months
Negative predictive value of optical enhancement endoscopy in diagnosis of gastric neoplasia
Measured: 8 months
Secondary outcomes (1)
The inter-observer and intra-observer agreement of optic enhancement endoscopy in gastric neoplasia
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric NeoplasiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 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, PhD. MD., Study director, Department of Gastroenterology, Qilu Hospital, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863965
- Sponsor's protocol ID
- 2016SDU-QILU-13
- Status last verified
- Jul 2016
- First submitted
- 30 Jul 2016
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Definition Endoscopy and Optic Enhancement Endoscopy in Gastric Neoplasia: A Prospective Study
- ClinicalTrials.gov ID
- NCT02863965
- Acronym / sponsor ID
- 2016SDU-QILU-13
- Conditions
- Gastric Neoplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Oct 2016 (estimated)
- First posted
- 11 Aug 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.
The aim of the study is to evaluate the diagnostic value of high definition endoscopy and optic enhancement in gastric neoplasia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High definition endoscopy and optic enhancement | – | –All the patients underwent routine preparation before the procedure. The detected lesions in high definition endoscopy were observed with optic enhancement mode. The endoscopist was required to give the real-time descriptions of surface pit patterns of the lesions, based on surface pattern classification. After that, biopsy specimens will be obtained respectively by forceps from each detected lesion recorded for histologic diagnosis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with dyspeptic symptoms and aged 40 years or older, or with Helicobacter pylori infection, histologically verified gastric intestinal metaplasia or atrophic gastritis, or with family history of gastric cancer
Key inclusion criteria (3 listed)
- patients with dyspeptic symptoms and aged 40 years or older
- or patients with Helicobacter pylori infection, or histologically verified gastric intestinal metaplasia or atrophic gastritis
- or patients with family history of gastric cancer
Key exclusion criteria (3 listed)
- presence of gastrectomy, acute gastrointestinal bleeding, or known gastric neoplasia
- presence of conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding
- inability to provide informed consent
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
Sensitivity of optical enhancement endoscopy in diagnosis of gastric neoplasia
Time frame: 8 months
Specificity of optical enhancement endoscopy in diagnosis of gastric neoplasia
Time frame: 8 months
Positive predictive value of optical enhancement endoscopy in diagnosis of gastric neoplasia
Time frame: 8 months
Negative predictive value of optical enhancement endoscopy in diagnosis of gastric neoplasia
Time frame: 8 months
1 secondary outcome
The inter-observer and intra-observer agreement of optic enhancement endoscopy in gastric neoplasia
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 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.
Yanqing Li, PhD. MD. study director
Department of Gastroenterology, Qilu Hospital, 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 Gastric Neoplasia, 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 3 inclusion and 3 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 11 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanqing Li, PhD. MD. (18678827666, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of optical enhancement endoscopy in diagnosis of gastric neoplasia (time frame: 8 months). The study lists 4 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 11 Aug 2016.