Development and Validation of a Survival Prediction Model for Esophageal Cancer Patients After Esophagectomy

Survivorship Clinical Trial

— OSmodel  

Official title:

Development and Validation of A Overall Survival Prediction Model for Esophageal Squamous Cell Carcinoma: A Novel pN Classification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06169930
• Other study ID #: SCCH-TS2207
• Status: Completed
• Start date: December 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2023
• Source: Sichuan Cancer Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2957
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Survivorship

Intervention

Other:
• This was an observational study without any intervention
This was an observational study without any intervention

Locations

Country	Name	City	State
China	Sichuan Cancer Hospital and Research Institute	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Yongtao Han

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	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