Follow-up Strategy for Esophageal Cancer Patients

September 13, 2023 updated by: Jianhua Fu, Sun Yat-sen University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Jianhua Fu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Chinese patients with historically proven esophageal squamous cell carcinoma and adenocarcinoma

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
follow-up
patients were follow-up with different time intervals
Other: follow-up with different time intervals
After radical surgery, patients are followed up with different time intervals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease-free survival
Time Frame: 2008-2020
disease-free survival
2008-2020

Secondary Outcome Measures

Outcome Measure
Time Frame
local relapse-free survival
Time Frame: 2008-2020
2008-2020
distant metastasis-free survival
Time Frame: 2008-2020
2008-2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20220820

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to the policy, we could not shared the data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe