NCT06716593

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 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

September 12, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2024

Completed
Last Updated

December 4, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

November 29, 2024

Last Update Submit

November 29, 2024

Conditions

Locally Advanced Gastric CancerTrajectory

Keywords

locally advanced gastric cancerneoadjuvant chemotherapycachexiaCTadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

  • 3-year overall survival; 5-year overall survival

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

    3 years or 36 months; 5 years or 60months

Eligibility Criteria

Age18 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

MeSH Terms

Conditions

Cachexia

Condition Hierarchy (Ancestors)

Weight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Study Officials

  • Chang-Ming Huang, M.D. FACS

    Fujian Medical University Union Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D. FACS

Study Record Dates

First Submitted

November 29, 2024

First Posted

December 4, 2024

Study Start

September 12, 2024

Primary Completion

November 27, 2024

Study Completion

November 30, 2024

Last Updated

December 4, 2024

Record last verified: 2024-11

Locations

CN(1)