Development and Validation of a Survival Prediction Model... | NCT06169930

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

NCT06169930

Sponsor

Yongtao Han

Status

Completed

Last Update Posted

Dec 14, 2023Actual

Enrollment

2,957Actual

Phase

Not provided

Conditions

Survivorship

Interventions

This was an observational study without any intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Actual

Primary Completion Date

Dec 1, 2023Actual

Completion Date

Dec 1, 2023Actual

First Submitted Date

Dec 3, 2023

First Submission Date that Met QC Criteria

Dec 13, 2023

First Posted Date

Dec 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2023

Last Update Posted Date

Dec 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,957Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
high-risk			Other: This was an observational study without any intervention
low-risk			Other: This was an observational study without any intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
This was an observational study without any intervention	Other	This was an observational study without any intervention	high-risk low-risk

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients from the Sichuan Cancer Hospital & Institute Esophageal Cancer Case Management Database (SCH-ECCM Database) from January 2010 to December 2017.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sichuan Cancer Hospital and Research Institute		Chengdu	Sichuan	610041	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided