High Risk Population of Gastric CancerNCT04720521
Application of OE in Diagnosis of EGC
A study testing OE+white light in people with High Risk Population of Gastric Cancer, run by Changhai Hospital at 1 site in China.
Trial summary
The main purpose of this study is to evaluate application value of OE mode 2 in the diagnosis of early gastric cancer The Secondary purpose is to evaluate application value of OE mode 1 in differentiating the diagnosis of neoplastic lesions of the gastric mucosa. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- High Risk Population of Gastric Cancer
- What is being tested?
- OE+white light
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,454 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2019to 10 May 2021
- Phase
- Interventional
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meet item 1or 2 + any items of 3-7
- Male ≥ 40 years old, female ≥ 50 years old.
- More than one year since the last gastroscopy.
- Patients from the areas with high incidence of stomach cancer (Shandong Province, Liaoning Province, Fujian Province, Gansu Province, Qinghai Province, Ningxia Province, Jilin Province, Jiangsu Province, Shanghai).
- Patients with pre-cancerous gastric diseases such as chronic atrophic gastritis, gastric ulcer, gastric polyp, hypertrophic gastritis, pernicious anemia, etc. in the past.
- First-degree relatives of patients with a family history of gastric cancer.
- Other high-risk life factors for gastric cancer (high salt, pickled diet, smoking, heavy alcohol consumption, etc.)
- Positive serum gastric function tests (GastroPanel) include: H. pylori (H.P) antibody （+）, Fasting pepsinogen I and II ratio (PG I/PGII) <3.89, gastrin 17 (G-17) >1.50 pmol/L.
Who cannot join
- Patients who have undergone invasive treatment such as surgical resection, PEG, chemotherapy etc. of either stomach or oesophagus. (except for EMR and ESD).
- Patients with a confirmed diagnosis of progressive cancer above T2 degreed according to the TMN classification of cancer。
- Patients on anticoagulants that cannot be biopsied.
- Patients who have undergone gastrectomy.
- Patients who have taken PPIs or H2 receptor antagonist within two weeks.
- Patients with history of malignant neoplasm; high suspicion of neoplasm; severe cardiac, pulmonary, hepatic or renal insufficiency; severe mental illness and pregnant women.
- Patients who did not signed the consent form.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Changhai Hospital, Second Military Medical University
Shanghai, Shanghai Municipality, 200433
About this study
Official title: Application of OpticalEnhancement Endoscopy（OE） in Diagnosis of Early Gastric Cancer: a Multicenter, Prospective, Randomized Controlled Study
The main purpose of this study is to evaluate application value of OE mode 2 in the diagnosis of early gastric cancer The Secondary purpose is to evaluate application value of OE mode 1 in differentiating the diagnosis of neoplastic lesions of the gastric mucosa.
Read the detailed description
Gastric cancer is the most prevalent cancer in China，while the detection rate of early gastric cancer is lower than 10%. An effective screening method to improve the detection rate is urgently needed. Optical Enhancement (OE) mode is an endoscopic mode that uses the principle of grating for electronic staining, which provides a clear picture of the submucosal and superficial mucosal vascular structures. The OE1 mode provides enhanced images of the gastric Gland tube and blood vessels, as well as magnification. The OE2 mode is used to identify small chromatic aberrations and to visualize superficial structures in the gastric mucosa. So we designed this randomized controlled trial to discuss effectiveness of OE in the diagnosis of early gastric cancer and we hope to find an effective method to improve the detection rate of early gastric cancer in China.
- Conditions
- High Risk Population of Gastric Cancer
- Being tested
- OE+white light
- Keywords
- early gastric cancer, Optical Enhancement, Detection Rate
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OE+white lightDiagnostic test
Firstly use white light to observe from esophagus to duodenum and then switch OE mode to observe from antrum to esophagus
| Study group | Role | What they receive |
|---|---|---|
| OE+white light | Experimental | Using white light firstly to observe from esophagus to duodenum and then switch OE mode to observe from antrum to esophagus. Receives: Diagnostic Test: OE+white light |
| White light | No intervention | Using White light to observe from esophagus to duodenum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of gastric neoplastic lesion
Include early gastric cancer, high-grade neoplasia, low-grade neoplasia and adenoma
Measured: procedure
Secondary outcomes (2)
Specificity of detecting gastric neoplastic lesion
Measured: procedure
Sensitivity of detecting gastric neoplastic lesion
Measured: procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start10 May 2019
- Primary completion10 Mar 2021 (estimated)
- Study completion10 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for High Risk Population of Gastric CancerStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,454 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, Shengjing Hospital, Zhengzhou Central Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Tang-Du Hospital, Sino-Japanese Friendship Hospital of Jilin University, First People's Hospital of Hangzhou, Nanjing First Hospital, Nanjing Medical University, Peking University Cancer Hospital & Institute, The First People's Hospital of Guangzhou, First Affiliated Hospital of Guangxi Medical University, Tongji Hospital
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhao shen Li, M.D., Principal investigator, Department of Gastroenterology, Changhai Hospital, Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720521
- Sponsor's protocol ID
- OE2021
- Status last verified
- Jan 2021
- First submitted
- 20 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gomez JM, Wang AY. Gastric intestinal metaplasia and early gastric cancer in the west: a changing paradigm. Gastroenterol Hepatol (N Y). 2014 Jun;10(6):369-78.
PubMed 25013389Nagao M, Nishikawa J, Ogawa R, Sasaki S, Nakamura M, Nishimura J, Goto A, Hashimoto S, Okamoto T, Suenaga M, Hamamoto Y, Sakaida I. Evaluation of the Diagnostic Ability of Optical Enhancement System in Early Gastric Cancer Demarcation. Gastroenterol Res Pract. 2016;2016:2439621. doi: 10.1155/2016/2439621. Epub 2016 Sep 28.
PubMed 27774101
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of OpticalEnhancement Endoscopy（OE） in Diagnosis of Early Gastric Cancer: a Multicenter, Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04720521
- Acronym / sponsor ID
- OE2021
- Conditions
- High Risk Population of Gastric Cancer
- Keywords
- early gastric cancer, Optical Enhancement, Detection Rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,454 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, Shengjing Hospital, Zhengzhou Central Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Tang-Du Hospital, Sino-Japanese Friendship Hospital of Jilin University, First People's Hospital of Hangzhou, Nanjing First Hospital, Nanjing Medical University, Peking University Cancer Hospital & Institute, The First People's Hospital of Guangzhou, First Affiliated Hospital of Guangxi Medical University, Tongji Hospital
- Study start
- 10 May 2019 (actual)
- Primary completion
- 10 Mar 2021 (estimated)
- Study completion
- 10 May 2021 (estimated)
- First posted
- 22 Jan 2021 (actual)
- 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 main purpose of this study is to evaluate application value of OE mode 2 in the diagnosis of early gastric cancer The Secondary purpose is to evaluate application value of OE mode 1 in differentiating the diagnosis of neoplastic lesions of the gastric mucosa.
Detailed description
Gastric cancer is the most prevalent cancer in China，while the detection rate of early gastric cancer is lower than 10%. An effective screening method to improve the detection rate is urgently needed. Optical Enhancement (OE) mode is an endoscopic mode that uses the principle of grating for electronic staining, which provides a clear picture of the submucosal and superficial mucosal vascular structures. The OE1 mode provides enhanced images of the gastric Gland tube and blood vessels, as well as magnification. The OE2 mode is used to identify small chromatic aberrations and to visualize superficial structures in the gastric mucosa. So we designed this randomized controlled trial to discuss effectiveness of OE in the diagnosis of early gastric cancer and we hope to find an effective method to improve the detection rate of early gastric cancer in China.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OE+white light | Experimental | Diagnostic Test: OE+white lightUsing white light firstly to observe from esophagus to duodenum and then switch OE mode to observe from antrum to esophagus. |
| White light | No intervention | –Using White light to observe from esophagus to duodenum. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Meet item 1or 2 + any items of 3-7
- Male ≥ 40 years old, female ≥ 50 years old.
- More than one year since the last gastroscopy.
- Patients from the areas with high incidence of stomach cancer (Shandong Province, Liaoning Province, Fujian Province, Gansu Province, Qinghai Province, Ningxia Province, Jilin Province, Jiangsu Province, Shanghai).
- Patients with pre-cancerous gastric diseases such as chronic atrophic gastritis, gastric ulcer, gastric polyp, hypertrophic gastritis, pernicious anemia, etc. in the past.
Key exclusion criteria (7 listed)
- Patients who have undergone invasive treatment such as surgical resection, PEG, chemotherapy etc. of either stomach or oesophagus. (except for EMR and ESD).
- Patients with a confirmed diagnosis of progressive cancer above T2 degreed according to the TMN classification of cancer。
- Patients on anticoagulants that cannot be biopsied.
- Patients who have undergone gastrectomy.
- Patients who have taken PPIs or H2 receptor antagonist within two weeks.
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 |
|---|---|---|
| OE+white lightFirstly use white light to observe from esophagus to duodenum and then switch OE mode to observe from antrum to esophagus | Diagnostic test | OE+white light |
Primary outcome
Detection rate of gastric neoplastic lesion
Time frame: procedure
Include early gastric cancer, high-grade neoplasia, low-grade neoplasia and adenoma
2 secondary outcomes
Specificity of detecting gastric neoplastic lesion
Time frame: procedure
Sensitivity of detecting gastric neoplastic lesion
Time frame: procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Results publication: PubMed 25013389Gomez JM, Wang AY. Gastric intestinal metaplasia and early gastric cancer in the west: a changing paradigm. Gastroenterol Hepatol (N Y). 2014 Jun;10(6):369-78.
- Results publication: PubMed 27774101Nagao M, Nishikawa J, Ogawa R, Sasaki S, Nakamura M, Nishimura J, Goto A, Hashimoto S, Okamoto T, Suenaga M, Hamamoto Y, Sakaida I. Evaluation of the Diagnostic Ability of Optical Enhancement System in Early Gastric Cancer Demarcation. Gastroenterol Res Pract. 2016;2016:2439621. doi: 10.1155/2016/2439621. Epub 2016 Sep 28.
- 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.
Zhao shen Li, M.D. principal investigator
Department of Gastroenterology, Changhai Hospital, Second Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OE+white light in people with High Risk Population of Gastric Cancer, run by Changhai Hospital 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 8 inclusion and 7 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 22 Jan 2021. 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 Liang hao Hu, M.D. (8613817593520, lianghao-hu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of gastric neoplastic lesion (time frame: procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04720521, which also lists 2 linked publications.
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 22 Jan 2021.