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NCT06045715 Clinical Trial

Follow-up Strategy for Esophageal Cancer Patients

Esophagus Cancer Clinical Trial

Official title:
An Optimized Post-surgery Follow-up Strategy for Patients With Esophageal Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06045715
Other study ID # 20220820
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 20, 2022
Est. completion date December 2023

Study information
Verified date September 2022
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 3000
Est. completion date December 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• follow-up with different time intervals
After radical surgery, patients are followed up with different time intervals

Locations
Country Name City State
China Jianhua Fu Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary disease-free survival disease-free survival 2008-2020
Secondary local relapse-free survival 2008-2020
Secondary distant metastasis-free survival 2008-2020
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