LCI in Chronic Atrophic Gastritis and Early Gastric Cancer

NCT06152263 | Unknown

• 1 other identifier: LCI in CAG and EGC
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CAG - Chronic Atrophic Gastritis; EGC - Early Gastric Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  up to 4 weeks

• 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.

  up to 2 weeks

Study Arms (2)

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

Compare color information and mucosal microvascular density OTHER

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

Atrophic or Cancerous

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with CAG or EGC by esophagogastroduodenoscopy

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Affiliated Hospital to Academy of Military Medical Sciences: lead

Study Sites (1)

The Fifth Medical Center of Chinese PLA General Hosptial

Beijing, Beijing Municipality, 100039, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Endoscopic biopsy or resection will be performed, and the mucosal microvascular density will be histopathologically analyzed using the specimens.

MeSH Terms

Conditions

Gastritis, Atrophic; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Yan Liu, MD

  The Fifth Medical Center of Chinese PLA General Hosptial

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang Wu, MD

CONTACT

+8613911058553; wuliangdoc@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2023
• First Posted: November 30, 2023
• Study Start: September 30, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 30, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)