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CompletedNCT06716593FJMUGS-2411Updated Dec 4, 2024

Trajectory of Body Composition Identifies LAGC with Cachexia Following NACT

An observational study in Locally Advanced Gastric Cancer and Trajectory, sponsored by Chang-Ming Huang, Prof.. Completed at 1 site in China. Open to participants aged 18 Years to 84 Years. Per ClinicalTrials.gov, last updated 2024-12-04.

Sponsored by Chang-Ming Huang, Prof. · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
600
Ages
18 Years to 84 Years
Sex
All
01

Study summary

This longitudinal, multicentre cohort study included LAGC patients treated with NACT between 01/2010-12/2021. BC measurements including skeletal muscle mass (SMM) and total adipose tissue area (TATA) were evaluated by computed tomography at the third lumbar vertebra at baseline and follow-up imaging. Unsupervised latent class growth mixed models were applied to distinguish potential longitudinal SMM and TATA trajectories for identifying cachexia. The primary study endpoint was overall survival (OS), with secondary endpoints including Recurrence-free survival (RFS), objective response rate (ORR) and safety. Multiple Cox proportional hazards models were used to calculate adjusted hazard ratios (HRs) for survival.

Read the detailed description

This is a retrospective, longitudinal, multicenter, real-world cohort study

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Conditions studied

  • Locally Advanced Gastric Cancer
  • Trajectory

Keywords

  • locally advanced gastric cancer
  • neoadjuvant chemotherapy
  • cachexia
  • CT
  • adjuvant chemotherapy
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In context

Stomach Neoplasms

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

This study's enrollment of 600 is above the median of 274 across 670 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Chang-Ming Huang, Prof. is the lead sponsor of 9 studies on the registry; none are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Data were collected from 600 consecutive patients diagnosed with locally advanced gastric cancer (cT2-4NanyM0) between 2010, and 2021, identified at 5 tertiary hospitals

Eligibility criteria

Inclusion Criteria:(1) locally advanced gastric cancer (cT2-4NxM0) with clinical staging before neoadjuvant chemotherapy, (2) no history of other malignant tumors, (3) no evidence of distant metastasis or invasion of adjacent organs, and (4) patients who underwent radical gastrectomy following neoadjuvant chemotherapy.

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Exclusion Criteria: (1) history of gastric surgery; (2) acute cardiovascular disease (such as cerebrovascular or coronary artery injury) within the past three months; (3) emergency surgery; (4) active infection or severe systemic immunodeficiency; and (5) incomplete serological, computed tomography, or anthropometric data.

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
600 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 3-year overall survival; 5-year overall survival

    Survival status at 3/5 years: survival, death, survival with tumor, deletion.

    Time frame: 3 years or 36 months; 5 years or 60months

07

Study locations

1 site
  • Fujian Medical University Union Hospital
    Fuzhou, Fujian 350001, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06716593
Lead sponsor
Chang-Ming Huang, Prof.
Responsible party
Chang-Ming Huang, Prof. (M.D. FACS, Fujian Medical University) — Sponsor-investigator
First posted
Dec 4, 2024
Start date
Sep 12, 2024
Primary completion
Nov 27, 2024
Completion
Nov 30, 2024
Last update
Dec 4, 2024

Study contacts

Chang-Ming Huang, M.D. FACS
principal investigator · Fujian Medical University Union Hospital

Oversight

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

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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