Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Application of Linked Color Imaging（LCI） in Diagnosis of Early Gastric Cancer(EGC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03661671
Recruitment Status : Unknown
Verified September 2018 by Zhaoshen Li, Changhai Hospital.
Recruitment status was:  Recruiting
First Posted : September 7, 2018
Last Update Posted : September 7, 2018
Sponsor:
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
Information provided by (Responsible Party):
Zhaoshen Li, Changhai Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
the purpose of this study is to evaluate application value of LCI in the diagnosis of early gastric cancer.

Condition or disease Intervention/treatment Phase
Early Gastric Cancer Diagnostic Test: LCI+white light Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Application of Linked Color Imaging（LCI） in Diagnosis of Early Gastric Cancer(EGC): a Multicenter,Prospective, Randomized Controlled Study
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: LCI+white light
Using white light firstly to observe from cardia to duodenum and then switch LCI model to observe from antrum to cardia
 Diagnostic Test: LCI+white light
Firstly use white light to observe from cardia to duodenum and then switch LCI model to observe from antrum to cardia
No Intervention: White light
Using white light only.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Detection rate of gastric neoplastic lesion [ Time Frame: immediately following the procedure ]
    Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma


Secondary Outcome Measures :
  1. Specificity of detecting gastric neoplastic lesion [ Time Frame: immediately following the procedure ]
    Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma

  2. Sensitivity of detecting gastric neoplastic lesion [ Time Frame: immediately following the procedure ]
    Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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;
  2. First degree relatives of patients with gastric cancer;
  3. There are other high risk factors for gastric cancer (high salt, salted diet, smoking, heavy drinking, etc.).
  4. Patients with early gastric cancer treated with endoscopic therapy (ESD, EMR).
  5. The informed consent has been signed.

Exclusion Criteria:

  1. The TNM classification of cancer is consistent with those diagnosed by T2 above.
  2. Patients with abnormal blood coagulation function or taking anticoagulants can not biopsy.
  3. There were contraindications for gastroscopy.
  4. A patient without self judgement;
  5. Those who did not sign informed consent.
  6. Previous gastroscopy has found suspicious lesions requiring careful examination.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661671


Contacts
Layout table for location contacts
Contact: Dong Wang, M.D 8613816758802 dongwang0901@sina.com
Contact: Jie Gao, M.D 8613761272863 jesseegao@163.com

Locations
Layout table for location information
China, Shanghai
Department of Gastroenterology, Changhai Hospital, Second Military Medical University Recruiting
Shanghai, Shanghai, China, 200433
Contact: Dong Wang, MD    008613816758802    dongwang0901@sina.com   
Sponsors and Collaborators
Changhai Hospital
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
Investigators
Layout table for investigator information
Principal Investigator: Zhaoshen Li, M.D Department of Gastroenterology, Changhai Hospital, Second Military Medical University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Zhaoshen Li, Director of Gastroenterology Dept, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03661671    
Other Study ID Numbers: LCI2018
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhaoshen Li, Changhai Hospital:
Linked-color imaging
Detection
Additional relevant MeSH terms:
Layout table for MeSH terms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases