A New Prognostic Score Model for Pancreatic Ductal Adenocarcinoma

Completed

• Conditions: Neoplasms Pancreatic
• Interventions: Procedure: pancreatic cancer surgery

• Registration Number: NCT05547074
• Lead Sponsor: Zhejiang University

Brief Summary

The AJCC TNM staging system is the prevailing method in prognostic evaluation of pancreatic ductal adenocarcinoma (PDAC) at present , but it did not include factors such as the tumor immune microenvironment that are known to exert a profound impact on patients'clinical outcome. This study was aimed to develop a comprehensive and effective prognostic score model to predict prognosis and guide clinical management for postoperative PDAC patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2020-10-30
• Study Completion: 2022-08-31
• Status Verified: 2022-09
• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-15
• Last Update Submitted: 2022-09-20
• Study First Posted: 2022-09-21
• Last Update Posted: 2022-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

Inclusion Criteria

1. Pathologically confirmed PDAC
2. Achievement of surgical resection (including radical or palliative surgery)

Exclusion Criteria

1. Lost to follow-up
2. Simultaneous presence of other tumors
3. Died in three months after surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The training cohort	pancreatic cancer surgery	To develop the prognostic model, 302 cases of postoperative PDAC were included in the final analysis and divided into the training and validation cohort by stratified sampling with 7:3 ratio (The training cohort: n=212; The validation cohort: n=90).
The validation cohort	pancreatic cancer surgery	To develop the prognostic model, 302 cases of postoperative PDAC were included in the final analysis and divided into the training and validation cohort by stratified sampling with 7:3 ratio (The training cohort: n=212; The validation cohort: n=90).

Primary Outcome Measures

Name	Time	Method
overall survival	after pancreatic cancer surgery until october 31, 2020	the number of months from the date of surgery to the date of the last follow-up visit or time of death.

Secondary Outcome Measures

Name	Time	Method
disease-free survival disease-free survival disease-free survival disease-free survival	after pancreatic cancer surgery until october 31, 2020	the number of months from the date of surgery to the date of first confirmable recurrence or death

Trial Locations

Locations (1)

First Affiliated Hospital, Medical College of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China