NCT06337279

Brief Summary

The Systemic Oxidative Stress Score (SOSS) , a comprehensive score reflecting the oxidative stress conditions in the microenvironment, can independently and effectively predict tumor burden and long-term prognosis in GC patients. Nomograms based on SOSS provide a potential and promising model for risk stratification and guiding the implementation of treatment decisions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,820

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

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

December 10, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 29, 2024

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

8 months

First QC Date

March 22, 2024

Last Update Submit

March 22, 2024

Conditions

Keywords

Oxidative stressGastric cancerRecurrenceDisease-free survivalSystemic Oxidative Stress Score

Outcome Measures

Primary Outcomes (2)

  • 5-year OS

    Overall survival, death, survival with tumor, deletion.

    5 years or 60 months

  • 5-year DFS

    Disease-free survival, death,recurrence

    5 years or 60 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study is a multicenter, retrospective cohort investigation involving GC patients who underwent radical gastrectomy at the Fujian Medical University Union Hospital (FMUUH), the First Affiliated Hospital of Gannan Medical University (FAHGMU) and Quzhou Affiliated Hospital of Wenzhou Medical University (QAHWMU) between January 2009 and June 2020.

You may qualify if:

  • \) gastroscopic histopathological diagnosis of gastric adenocarcinoma; 2) radical gastrectomy for GC; 3) preoperative examination of oxidative indicators including Fbg, CHOL, ALB, TBIL, DBIL, and CR within seven days before surgery; and 4) the tumor did not invade neighboring organs or had no distant metastasis.

You may not qualify if:

  • \) gastroscopic histopathological diagnosis of non-adenocarcinoma, 2) gastric stump cancer, 3) neoadjuvant chemotherapy, 4) other malignant diseases besides GC, 5) incomplete medical records, and 6) patients with GC lost to follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

Location

MeSH Terms

Conditions

Stomach NeoplasmsRecurrence

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Changming Huang, Prof.

    Fujian Medical University Union Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 22, 2024

First Posted

March 29, 2024

Study Start

December 10, 2022

Primary Completion

August 20, 2023

Study Completion

March 20, 2024

Last Updated

March 29, 2024

Record last verified: 2024-03

Locations