NCT07109271

Brief Summary

Gastric carcinoma remains the fifth most common malignancy and the second leading cause of cancer-related mortality worldwide. For patients with locally advanced disease, standard treatment includes radical gastrectomy followed by (neo)adjuvant chemotherapy and immune checkpoint inhibitors. Considerable variability in prognosis persists even within the same the American Joint Committee on Cancer (AJCC) substage, highlighting the importance of host-related factors such as nutritional status, systemic inflammation, and immune competence in shaping survival. Computed tomography-based body composition (CTBC) analysis offers an objective means to quantify skeletal muscle, subcutaneous adipose tissue, and visceral adipose tissue, capturing key dimensions of patient physiology that are not accounted for in traditional staging systems. Advances in deep learning enables rapid, automated body composition analysis with high concordance to expert annotations. Here, the investigators prepare to apply automated CTBC analysis to a homogeneous cohort of 300 patients with AJCC8 stage III gastric cancer to determine whether visceral adiposity-related metrics improve survival risk stratification beyond TNM staging.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
227

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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, 2007

Completed
16 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

16 years

First QC Date

June 29, 2025

Last Update Submit

August 6, 2025

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (2)

  • disease free survival and overall survival

    months

    January 2007 to December 2022

  • body mass index

    kg/m\^2

    January 2007 to December 2022

Study Arms (1)

VAT-to-SAT ratio high vs VAT-to-SAT ratio low

VAT/SAT ratio indicates body fat distribution

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

AJCC stage III gastric cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ta-Sen Yeh

Taoyuan District, 886, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

surgical specimen with paraffin block

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 29, 2025

First Posted

August 7, 2025

Study Start

January 1, 2007

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)