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RecruitingNCT06152263Updated Dec 14, 2023

LCI in Chronic Atrophic Gastritis and Early Gastric Cancer

An observational study in CAG - Chronic Atrophic Gastritis and EGC - Early Gastric Cancer, sponsored by Affiliated Hospital to Academy of Military Medical Sciences. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-12-14.

Sponsored by Affiliated Hospital to Academy of Military Medical Sciences · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 9 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
10
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Color change is a useful marker for the endoscopic identification of chronic atrophic gastritis (CAG) and gastric cancer (GC). Several histopathological studies have suggested a correlation between certain gastrointestinal lesions and intramucosal vascularity. The aim of this study is to investigate the association between the color and mucosal microvascular density of CAG and early GC using linked color imaging (LCI). In this study, Lesions diagnosed as CAG and early GC will be observed using LCI. In each image, the color values of atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa, will be quantified using the International Commission on Illumination 1976 (L∗, a∗, b∗) color space. Histological microvascular density in biopsy or resected specimens will be evaluated using CD31 immunostaining. Color differences at the atrophic border and cancerous border, defined as Euclidean distances of color values between the atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa, will be calculated according to mucosal microvascular density.

Read the detailed description

In this study, 10 patients diagnosed with CAG or early GC by esophagogastroduodenoscopy at Fifth Medical Center of Chinese PLA General Hospital between September 2023 and December 2023 will be enrolled. The following equipment will be used for the study: LCI endoscope (EG-760Z, FUJIFILM Co., Tokyo, Japan), light sources (LASEREO LL-4450; Fujifilm Co.), and video processors (AdvanciaHD VP-4450HD; FUJIFILM Co.). During esophagogastroduodenography, the atrophic or cancerous border will be identified. Following identical compositions, images will be continuously captured via LCI. Endoscopic biopsy or resection will be performed, and the mucosal microvascular density will be histopathologically analyzed using the specimens. The color values of atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa, will be quantified using the International Commission on Illumination 1976 (L∗, a∗, b∗) color space. Histological microvascular density in biopsy or resected specimens will be evaluated using CD31 immunostaining. Color differences at the atrophic border and cancerous border, defined as Euclidean distances of color values between the atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa, will be calculated according to mucosal microvascular density.

02

Conditions studied

  • CAG - Chronic Atrophic Gastritis
  • EGC - Early Gastric Cancer

Keywords

  • color information
  • linked color imaging
  • mucosal microvascular density
  • chronic atrophic gastritis
  • early gastric cancer
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 10 is below the median of 274 across 670 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Affiliated Hospital to Academy of Military Medical Sciences is the lead sponsor of 65 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with CAG or EGC by esophagogastroduodenoscopy

Inclusion criteria

  • Patients diagnosed with chronic atrophic gastritis (CAG) and early gastric cancer (EGC). by esophagogastroduodenoscopy

Exclusion criteria

Exclusion Criteria:

  • Inappropriate LCI images as a result of bleeding, ulceration, or excessive mucosal congestion
  • Patients with severe anemia or portal hypertension
  • Patients diagnosed as having a mixture of the differentiated and undifferentiated types of gastric carcinoma, or having helicobacter pylori infection
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Atrophic or Cancerous

    In each image, the color values of atrophic or cancerous will be quantified using the International Commission on Illumination 1976 (L∗, a∗, b∗) color space. Histological microvascular density in biopsy or resected specimens will be evaluated using CD31 immunostaining. Color differences at the atrophic border and cancerous border, defined as Euclidean distances of color values between the atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa, will be calculated according to mucosal microvascular density.

    Other: Compare color information and mucosal microvascular density

  • Non-atrophic or Non-cancerous

    In each image, the color values of non-atrophic or non-cancerous will be quantified using the International Commission on Illumination 1976 (L∗, a∗, b∗) color space. Histological microvascular density in biopsy or resected specimens will be evaluated using CD31 immunostaining. Color differences at the atrophic border and cancerous border, defined as Euclidean distances of color values between the atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa, will be calculated according to mucosal microvascular density.

Interventions

  • OtherCompare color information and mucosal microvascular density

    To investigate the association between the color and mucosal microvascular density of CAG and EGC using linked color imaging.

06

What researchers measure

Primary outcomes

  1. Color differences between the atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa

    The color values of atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa, will be quantified by using the International Commission on Illumination 1976 (L∗, a∗, b∗) color space. It is speculated that there is a significant difference in the color difference between atrophic and non-atrophic mucosa and between cancerous and non-cancerous mucosa.

    Time frame: up to 4 weeks

  2. Microvascular density differences between the atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa

    Histological microvascular density of atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa, will be evaluated by using CD31 immunostaining. It is speculated that there is a significant difference in the mucosal microvascular density between atrophic and non-atrophic mucosa and between cancerous and non-cancerous mucosa.

    Time frame: up to 2 weeks

07

Study locations

1 of 1 sites recruiting
  • The Fifth Medical Center of Chinese PLA General Hosptial
    Beijing, Beijing 100039, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06152263
Lead sponsor
Affiliated Hospital to Academy of Military Medical Sciences
Responsible party
Sponsor
First posted
Nov 30, 2023
Start date
Sep 30, 2023
Primary completion
Dec 15, 2023 (estimated)
Completion
Dec 30, 2023 (estimated)
Last update
Dec 14, 2023

Study contacts

Liang Wu, MD
Contact
wuliangdoc@163.com
+8613911058553
Yan Liu, MD
principal investigator · The Fifth Medical Center of Chinese PLA General Hosptial

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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