Appraisal of the Modified Cancer Cachexia Index in Locally Advanced Gastric Cancer Patients Undergoing Neoadjuvant Chemotherapy

November 13, 2024 updated by: Chang-Ming Huang, Prof., Fujian Medical University
In this study, consecutive 600 patients with LAGC(cT2-4NanyM0) who underwent NACT between Jan. 2010 and Jun. 2022 were identified from two tertiary hospitals. The mCXI was constructed based on Random Forest model, calculated as (post-NACT L3 subcutaneous adipose tissue area [SAT])×(post-NACT serum albumin [ALB])/(post-NACT platelet count [PLT]). Patients were categorized into two subgroups: mCXI-low and mCXI-high. mCXI is associated with the overall prognosis in patients with locally advanced gastric cancer underwent neoadjuvant chemotherapy, is superior to traditional CXI, and may serve as a decision-making tool for guiding personalized postoperative adjuvant chemotherapy.

Study Overview

Status

Completed

Conditions

Detailed Description

This is a multicenter retrospective cohort study

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with locally advanced gastric cancer (cT2-4NanyM0)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year overall survival
Time Frame: 3 years or 36 months.
Survival status at 3 years: survival, death, the end of surgery to death.
3 years or 36 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University

Investigators

  • Principal Investigator: Chang-Ming Huang, M.D. FACS, Fujian Medical University Union Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

July 13, 2024

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

November 13, 2024

First Posted (Estimated)

November 14, 2024

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 13, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024NLAGCCachexia
  • 2022QNA026 (Other Grant/Funding Number: Fujian Medical University Union Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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