NCT06548464

Brief Summary

This multicenter, retrospective cohort study aimed to develop and validate an explainable prediction model for prognosis after gastrectomy in patients with gastric cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 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

June 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

August 6, 2024

Last Update Submit

August 9, 2024

Conditions

Keywords

Machine LearningPrognosisStomach NeoplasmsGastrectomy

Outcome Measures

Primary Outcomes (1)

  • Survival

    Assessment of overall survival outcomes in gastric cancer patients after gastrectomy.

    Up to 5 years after surgery

Secondary Outcomes (5)

  • Early Recurrence

    Within 2 years after surgery

  • Late Recurrence

    From 2 years up to 5 years after surgery

  • Postoperative Complications

    Within 30 days after surgery

  • Neoadjuvant Treatment Efficacy

    From initiation of neoadjuvant therapy to surgery (typically 2-3 months)

  • 5-Year Survival Rate

    5 years after surgery

Eligibility Criteria

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

This study includes adult patients of all genders who were diagnosed with primary gastric or gastroesophageal junction adenocarcinoma and underwent radical gastrectomy at participating institutions in China. The study population represents a diverse group of gastric cancer patients, varying in age, tumor stage, and treatment approaches, including those who received neoadjuvant therapy. This cohort aims to provide a comprehensive representation of gastric cancer patients treated with curative intent, allowing for the development and validation of prognostic models applicable to a wide range of clinical scenarios.

You may qualify if:

  • Patients diagnosed with primary gastric or gastroesophageal junction cancer
  • Underwent radical gastrectomy
  • Complete clinical and pathological data available

You may not qualify if:

  • Presence of distant metastases before surgery
  • Non-adenocarcinoma histology
  • Incomplete follow-up data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang-ming Huang

Fuzhou, Fujian, 350001, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Chang-Ming Huang, MD

    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
Professor

Study Record Dates

First Submitted

August 6, 2024

First Posted

August 12, 2024

Study Start

June 1, 2024

Primary Completion

August 1, 2024

Study Completion

August 6, 2024

Last Updated

August 12, 2024

Record last verified: 2024-08

Locations