Follow-up Strategy for Esophageal Cancer Patients

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT06045715
• Collaborator: (none)
• Enrollment: 3,000
• Location: 1
• Anticipated Duration (Months): 15.4
• Patients Per Site Per Month: 195.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophagus Cancer	Other: follow-up with different time intervals

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 Design

• Study Type: Observational
• Actual Enrollment: 3000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: An Optimized Post-surgery Follow-up Strategy for Patients With Esophageal Cancer
• Actual Study Start Date: Aug 20, 2022
• Actual Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. disease-free survival [2008-2020]

   disease-free survival

Secondary Outcome Measures

1. local relapse-free survival [2008-2020]

2. distant metastasis-free survival [2008-2020]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jianhua Fu	Guangzhou	Guangdong	China	510060

Sponsors and Collaborators

• Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jianhua Fu, Professor, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT06045715
• Other Study ID Numbers: 20220820
• First Posted: Sep 21, 2023
• Last Update Posted: Sep 21, 2023
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jianhua Fu, Professor, Sun Yat-sen University: follow-up
• Additional relevant MeSH terms: Esophageal Neoplasms

Study Results

No Results Posted as of Sep 21, 2023