- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06169930
Development and Validation of a Survival Prediction Model for Esophageal Cancer Patients After Esophagectomy (OSmodel)
December 13, 2023 updated by: Yongtao Han
Development and Validation of A Overall Survival Prediction Model for Esophageal Squamous Cell Carcinoma: A Novel pN Classification
In this retrospective study, we analyzed data from the Sichuan Cancer Hospital & Institute Esophageal Cancer Case Management Database (SCH-ECCM Database) from January 2010 to December 2017.
Our study focused on examining the clinicopathological characteristics, lymph node removal at each station, and treatment details of patients with esophageal squamous cell carcinoma (ESCC) who underwent esophagectomy.
Using this data, we developed a prediction model for OS by considering a combination of clinical characteristics and details of lymphadenectomy variables.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In this retrospective study, we analyzed data from the Sichuan Cancer Hospital & Institute Esophageal Cancer Case Management Database (SCH-ECCM Database) from January 2010 to December 2017.
Our study focused on examining the clinicopathological characteristics, lymph node removal at each station, and treatment details of patients with esophageal squamous cell carcinoma (ESCC) who underwent esophagectomy.
Using this data, we developed a prediction model for OS by considering a combination of clinical characteristics and details of lymphadenectomy variables.
Additionally, the receiver operating characteristic curve demonstrated an area under the curve greater than 0.7 at 1, 3, and 5 years in both the verification and training groups.
Furthermore, Kaplan-Meier (K-M) curves showed that our model effectively distinguished between high- and low-risk groups (p < 0.01).
Study Type
Observational
Enrollment (Actual)
2957
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
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
- Sichuan Cancer Hospital and Research Institute
-
-
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
N/A
Sampling Method
Non-Probability Sample
Study Population
Patients from the Sichuan Cancer Hospital & Institute Esophageal Cancer Case Management Database (SCH-ECCM Database) from January 2010 to December 2017.
Description
Inclusion criteria:
- Patients underwent esophagectomy at our hospital.
Exclusion criteria:
- pathology confirmed a non-squamous cell carcinoma,
- the tumor was located outside of the thoracic region,
- R1/R2 resection was performed indicating incomplete tumor removal,
- evidence of distant tumor metastasis was observed, or
- they underwent preoperative neoadjuvant therapy
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 |
|---|---|
|
high-risk
|
This was an observational study without any intervention
|
|
low-risk
|
This was an observational study without any intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Survival
Time Frame: April 2022-April 2024
|
Overall survival (OS) was defined as the time from the month and year of surgery until death or the last follow-up in April 2022.
|
April 2022-April 2024
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 1, 2023
Primary Completion (Actual)
December 1, 2023
Study Completion (Actual)
December 1, 2023
Study Registration Dates
First Submitted
December 3, 2023
First Submitted That Met QC Criteria
December 13, 2023
First Posted (Estimated)
December 14, 2023
Study Record Updates
Last Update Posted (Estimated)
December 14, 2023
Last Update Submitted That Met QC Criteria
December 13, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SCCH-TS2207
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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