Prediction Model for Advanced Gastric Cancer in Elderly

NCT06467591 | Completed DMC

• 1 other identifier: 2024KY076
• Study Type: observational
• Target: 1,436
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop and validate a Nomogram (mCNS) model for predicting long-term survival in elderly patients following curative resection for advanced gastric cancer. The study is a retrospective multi-center analysis involving 924 gastric cancer patients treated at the Department of Gastrointestinal Surgery of the Affiliated Union Hospital of Fujian Medical University between 2009 and 2013, and 512 patients aged 65 and above who underwent gastric resection at the Affiliated Zhongshan Hospital of Dalian University between 2011 and 2018. An online prognostic tool is introduced to assist clinicians in predicting patient prognosis and customizing treatment and follow-up strategies.

Conditions

Stomach Neoplasms; Aged

Keywords

Stomach Neoplasms; Prognosis; Elderly; Prediction Model

Outcome Measures

Primary Outcomes (1)

• 5-Year Overall Survival

  The proportion of patients who are alive at five years after treatment for elderly gastric cancer patients.

  5 years or 60 months.

Secondary Outcomes (2)

• 3-Year Overall Survival

  3 years or 36 months.

• 1-Year Overall Survival

  1 years or 12 months.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprises elderly patients, aged 65 and above, diagnosed with gastric cancer and who underwent curative gastrectomy within a ten-year period from January 2009 to December 2018. Participants were selected from two major tertiary care centers in China, ensuring a comprehensive representation of the demographic. Strict adherence to selection criteria ensured the use of a consistent and high-quality dataset for subsequent analysis in developing a robust prognostic model. The study focuses on the elderly demographic, addressing a significant gap in prognostic tools for this age group, which often presents with distinct clinical and therapeutic challenges.

You may qualify if:

• Confirmed as primary gastric adenocarcinoma by preoperative gastric endoscopy pathology;
• Underwent R0 laparoscopic radical gastrectomy for gastric cancer;
• Pathological stage T2-4a-N+;
• Age ≥ 65 years.

You may not qualify if:

• Pathological stage T1 and T2N0;
• Age \< 65 years;
• Presence of peritoneal or distant metastasis confirmed before or during surgery;
• Received neoadjuvant chemotherapy before surgery;
• Remnant gastric cancer;
• Emergency surgery or palliative exploratory surgery;
• Preoperative abdominal CT scan not available or preoperative examination time \> 1 month;
• Survival time less than 1 month;
• Incomplete clinical and pathological data.

Sponsors & Collaborators

• Chang-Ming Huang, Prof.: lead

Study Sites (1)

Department of Gastric Surgery， Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Chang-Ming Huang, M.D

  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: June 15, 2024
• First Posted: June 21, 2024
• Study Start: January 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 20, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

CN (1)