Follow-up Strategy for Esophageal Cancer Patients

Active, not recruiting

• Conditions: Esophagus Cancer
• Interventions: Other: follow-up with different time intervals

• Registration Number: NCT06045715
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The recurrence risk of patients with esophageal cancer was stratified by integrating different stages and pathological factors. The risk of recurrence was dynamically estimated for each group of patients, and the optimal follow-up strategy was developed based on the recurrence risk.

Detailed Description

Patients with histologically proven, esophageal cancer (EC) patients diagnosed between 2008 and 2018 were recruited. Recursive partition analysis was applied to develop recurrence risk stratification for patients. The follow-up strategies of each stratification were developed based on monthly recurrence probability and validated by bootstrap validation and an external dataset. Markov decision-analytic models were constructed to evaluate the cost-effectiveness of the follow-up strategies.

Study Timeline

• Study Start: 2022-08-20
• Status Verified: 2022-09
• Primary Completion: 2023-06-30
• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-09-13
• Last Update Submitted: 2023-09-13
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

(1) Patients aged between 18 and 80 years old; (2) Pathological diagnosis as esophageal squamous cell carcinoma or adenocarcinoma; (3) Patients underwent esophagectomy and received R0 resection.

Exclusion Criteria

(1) Patients with secondary primary tumor; (2) Patients who died within 30 days after surgery or died of post-operation complications; (3) Patients missing essential clinical information, such as operation record, pathological diagnosis, and follow-up data; (4) Patients with radiologically or histologically confirmed distant metastasis; (5) Patients previously underwent endoscopic mucosal resection or definitive radiochemotherapy as initial treatment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
follow-up	follow-up with different time intervals	patients were follow-up with different time intervals

Primary Outcome Measures

Name	Time	Method
disease-free survival	2008-2020	disease-free survival

Secondary Outcome Measures

Name	Time	Method
local relapse-free survival	2008-2020
distant metastasis-free survival	2008-2020

Trial Locations

Locations (1)

Jianhua Fu; 🇨🇳 Guangzhou, Guangdong, China