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Follow-up Strategy for Esophageal Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06045715
Recruitment Status : Active, not recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Jianhua Fu, Sun Yat-sen University

Study Description
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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
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
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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 : August 20, 2022
Actual Primary Completion Date : June 30, 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. disease-free survival [ Time Frame: 2008-2020 ]
    disease-free survival


Secondary Outcome Measures :
  1. local relapse-free survival [ Time Frame: 2008-2020 ]
  2. distant metastasis-free survival [ Time Frame: 2008-2020 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chinese patients with historically proven esophageal squamous cell carcinoma and adenocarcinoma
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06045715


Locations
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China, Guangdong
Jianhua Fu
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
More Information
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Responsible Party: Jianhua Fu, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT06045715    
Other Study ID Numbers: 20220820
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due to the policy, we could not shared the data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jianhua Fu, Sun Yat-sen University:
follow-up
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases