NCT03661671

Brief Summary

the purpose of this study is to evaluate application value of LCI in the diagnosis of early gastric cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

September 7, 2018

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

September 3, 2018

Last Update Submit

September 5, 2018

Conditions

Early Gastric Cancer

Keywords

Linked-color imagingDetection

Outcome Measures

Primary Outcomes (1)

  • Detection rate of gastric neoplastic lesion

    Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma

    immediately following the procedure

Secondary Outcomes (2)

  • Specificity of detecting gastric neoplastic lesion

    immediately following the procedure

  • Sensitivity of detecting gastric neoplastic lesion

    immediately following the procedure

Study Arms (2)

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

Diagnostic Test: LCI+white light

White light

NO INTERVENTION

Using white light only.

Interventions

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

LCI+white light

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Changhai Hospital, Second Military Medical University

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 26560036RESULT

  • Okada 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.

    PMID: 26867550RESULT

  • Sun 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.

    PMID: 27641243RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Zhaoshen Li, M.D

    Department of Gastroenterology, Changhai Hospital, Second Military Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Wang, M.D

CONTACT

8613816758802dongwang0901@sina.com

Jie Gao, M.D

CONTACT

8613761272863jesseegao@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Parallel assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Gastroenterology Dept

Study Record Dates

First Submitted

September 3, 2018

First Posted

September 7, 2018

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

September 7, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)