Early Gastric CancerNCT03661671
Application of Linked Color Imaging（LCI） in Diagnosis of Early Gastric Cancer(EGC)
A study testing LCI+white light in people with Early Gastric Cancer, run by Changhai Hospital at 1 site in China.
Trial summary
the purpose of this study is to evaluate application value of LCI in the diagnosis of early gastric cancer. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Gastric Cancer
- What is being tested?
- LCI+white light
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Jan 2019
- 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
- High-risk group of gastric cancer: H. pylori infection; previously suffering from chronic atrophic gastritis, intestinal metaplasia, gastric ulcer, gastric polyps, residual stomach after surgery, hypertrophic gastritis, malignant anemia and other precancerous diseases of gastric cancer;
- First degree relatives of patients with gastric cancer;
- There are other high risk factors for gastric cancer (high salt, salted diet, smoking, heavy drinking, etc.).
- Patients with early gastric cancer treated with endoscopic therapy (ESD, EMR).
- The informed consent has been signed.
Who cannot join
- The TNM classification of cancer is consistent with those diagnosed by T2 above.
- Patients with abnormal blood coagulation function or taking anticoagulants can not biopsy.
- There were contraindications for gastroscopy.
- A patient without self judgement;
- Those who did not sign informed consent.
- Previous gastroscopy has found suspicious lesions requiring careful examination.
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
Dong Wang, MD, 008613816758802, dongwang0901@sina.com
About this study
Official title: Application of Linked Color Imaging（LCI） in Diagnosis of Early Gastric Cancer(EGC): a Multicenter,Prospective, Randomized Controlled Study
the purpose of this study is to evaluate application value of LCI in the diagnosis of early gastric cancer.
Read the detailed description
The detection rate of early gastric cancer is still very low in China. The investigators need a new and effective screening method to improve the detection rate. LCI (linked-color imaging)is a new model of laser endoscopy which can provide brighter image. LCI can provide clear image which can make red part redder and white part whiter, so suspicious lesion could be found easier. The study of this randomized controlled trial is to discuss effectiveness of LCI in the diagnosis of early gastric cancer and to find a new method to improve the detection rate of early gastric cancer in China.
- Conditions
- Early Gastric Cancer
- Being tested
- LCI+white light
- Keywords
- Linked-color imaging, Detection
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCI+white lightDiagnostic test
Firstly use white light to observe from cardia to duodenum and then switch LCI model to observe from antrum to cardia
| Study group | Role | What they receive |
|---|---|---|
| LCI+white light | Experimental | Using white light firstly to observe from cardia to duodenum and then switch LCI model to observe from antrum to cardia Receives: Diagnostic Test: LCI+white light |
| White light | No intervention | Using white light only. |
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 caner,high grade dysplasia low grade dysplasia and adenoma
Measured: immediately following the procedure
Secondary outcomes (2)
Specificity of detecting gastric neoplastic lesion
Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma
Measured: immediately following the procedure
Sensitivity of detecting gastric neoplastic lesion
Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma
Measured: immediately following the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start1 Jan 2018
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Early 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
- Model description
- Parallel assignment
- Masking
- None (open label)
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanxi Province Cancer Hospital, First People's Hospital of Hangzhou, 307 Hospital of PLA, Jiangsu Province Hospital of Traditional Chinese Medicine, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Nanchang University, Zhongshan Hospital Xiamen University, Chongqing University Cancer Hospital, Guilin Medical University, China, Guangdong Provincial Hospital of Traditional Chinese Medicine, Xiangya Hospital of Central South University, Wuhan University, Xi'an Central Hospital
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhaoshen Li, M.D, Principal investigator, Department of Gastroenterology, Changhai Hospital, Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661671
- Sponsor's protocol ID
- LCI2018
- Status last verified
- Sep 2018
- First submitted
- 3 Sep 2018
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fukuda H, Miura Y, Hayashi Y, Takezawa T, Ino Y, Okada M, Osawa H, Lefor AK, Yamamoto H. Linked color imaging technology facilitates early detection of flat gastric cancers. Clin J Gastroenterol. 2015 Dec;8(6):385-9. doi: 10.1007/s12328-015-0612-9. Epub 2015 Nov 11.
PubMed 26560036Okada M, Sakamoto H, Takezawa T, Hayashi Y, Sunada K, Lefor AK, Yamamoto H. Laterally Spreading Tumor of the Rectum Delineated with Linked Color Imaging Technology. Clin Endosc. 2016 Mar;49(2):207-8. doi: 10.5946/ce.2015.077. Epub 2016 Feb 12. No abstract available.
PubMed 26867550Sun X, Dong T, Bi Y, Min M, Shen W, Xu Y, Liu Y. Linked color imaging application for improving the endoscopic diagnosis accuracy: a pilot study. Sci Rep. 2016 Sep 19;6:33473. doi: 10.1038/srep33473.
PubMed 27641243
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Linked Color Imaging（LCI） in Diagnosis of Early Gastric Cancer(EGC): a Multicenter,Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03661671
- Acronym / sponsor ID
- LCI2018
- Conditions
- Early Gastric Cancer
- Keywords
- Linked-color imaging, Detection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Shanxi Province Cancer Hospital, First People's Hospital of Hangzhou, 307 Hospital of PLA, Jiangsu Province Hospital of Traditional Chinese Medicine, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Nanchang University, Zhongshan Hospital Xiamen University, Chongqing University Cancer Hospital, Guilin Medical University, China, Guangdong Provincial Hospital of Traditional Chinese Medicine, Xiangya Hospital of Central South University, Wuhan University, Xi'an Central Hospital
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 7 Sep 2018 (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 purpose of this study is to evaluate application value of LCI in the diagnosis of early gastric cancer.
Detailed description
The detection rate of early gastric cancer is still very low in China. The investigators need a new and effective screening method to improve the detection rate. LCI (linked-color imaging)is a new model of laser endoscopy which can provide brighter image. LCI can provide clear image which can make red part redder and white part whiter, so suspicious lesion could be found easier. The study of this randomized controlled trial is to discuss effectiveness of LCI in the diagnosis of early gastric cancer and to find a new method to improve the detection rate of early gastric cancer in China.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| LCI+white light | Experimental | Diagnostic Test: LCI+white lightUsing white light firstly to observe from cardia to duodenum and then switch LCI model to observe from antrum to cardia |
| White light | No intervention | –Using white light only. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- High-risk group of gastric cancer: H. pylori infection; previously suffering from chronic atrophic gastritis, intestinal metaplasia, gastric ulcer, gastric polyps, residual stomach after surgery, hypertrophic gastritis, malignant anemia and other precancerous diseases of gastric cancer;
- First degree relatives of patients with gastric cancer;
- There are other high risk factors for gastric cancer (high salt, salted diet, smoking, heavy drinking, etc.).
- Patients with early gastric cancer treated with endoscopic therapy (ESD, EMR).
- The informed consent has been signed.
Key exclusion criteria (6 listed)
- The TNM classification of cancer is consistent with those diagnosed by T2 above.
- Patients with abnormal blood coagulation function or taking anticoagulants can not biopsy.
- There were contraindications for gastroscopy.
- A patient without self judgement;
- Those who did not sign 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LCI+white lightFirstly use white light to observe from cardia to duodenum and then switch LCI model to observe from antrum to cardia | Diagnostic test | LCI+white light |
Primary outcome
Detection rate of gastric neoplastic lesion
Time frame: immediately following the procedure
Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma
2 secondary outcomes
Specificity of detecting gastric neoplastic lesion
Time frame: immediately following the procedure
Sensitivity of detecting gastric neoplastic lesion
Time frame: immediately following the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Results publication: PubMed 26560036Fukuda H, Miura Y, Hayashi Y, Takezawa T, Ino Y, Okada M, Osawa H, Lefor AK, Yamamoto H. Linked color imaging technology facilitates early detection of flat gastric cancers. Clin J Gastroenterol. 2015 Dec;8(6):385-9. doi: 10.1007/s12328-015-0612-9. Epub 2015 Nov 11.
- Results publication: PubMed 26867550Okada M, Sakamoto H, Takezawa T, Hayashi Y, Sunada K, Lefor AK, Yamamoto H. Laterally Spreading Tumor of the Rectum Delineated with Linked Color Imaging Technology. Clin Endosc. 2016 Mar;49(2):207-8. doi: 10.5946/ce.2015.077. Epub 2016 Feb 12. No abstract available.
- Results publication: PubMed 27641243Sun X, Dong T, Bi Y, Min M, Shen W, Xu Y, Liu Y. Linked color imaging application for improving the endoscopic diagnosis accuracy: a pilot study. Sci Rep. 2016 Sep 19;6:33473. doi: 10.1038/srep33473.
- 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.
Zhaoshen 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 LCI+white light in people with Early 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 5 inclusion and 6 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 7 Sep 2018. 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 Dong Wang, M.D (8613816758802, dongwang0901@sina.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: immediately following the 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 NCT03661671, which also lists 3 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 7 Sep 2018.