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Trajectory of Body Composition Identifies LAGC with Cachexia Following NACT

NCT ID: NCT06716593

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-12

Study Completion Date

2024-11-30

Brief Summary

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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.

Detailed Description

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

Conditions

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Locally Advanced Gastric Cancer Trajectory

Keywords

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locally advanced gastric cancer neoadjuvant chemotherapy cachexia CT adjuvant chemotherapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang-Ming Huang, Prof.

OTHER

Sponsor Role lead

Responsible Party

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Chang-Ming Huang, Prof.

M.D. FACS

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Chang-Ming Huang, M.D. FACS

Role: PRINCIPAL_INVESTIGATOR

Fujian Medical University Union Hospital

Locations

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Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status

Countries

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China

Other Identifiers

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FJMUGS-2411

Identifier Type: -

Identifier Source: org_study_id