Trajectory of Body Composition Identifies LAGC with Cachexia Following NACT

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.

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Key information

Conditions

Locally Advanced Gastric Cancer Body Weight Body Weight Changes Cachexia Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness Trajectory Weight Loss

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

Primary outcomes

3-year overall survival; 5-year overall survival

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

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

Sponsors and collaborators

Lead sponsor

Chang-Ming Huang, Prof.

Other

Registry information

Official study title

Trajectory of Body Composition Identifies Locally Advanced Gastric Cancer with Cachexia Following Neoadjuvant Chemotherapy (FJMUGS-2411)

Acronym: FJMUGS-2411

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Dec 4, 2024
Registry last updated: Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed