A New Prognostic Score Model for Pancreatic Ductal Adenocarcinoma

Neoplasms Pancreatic Clinical Trial

Official title:

Development and Validation of a New Prognostic Score Model Combining TNM Stage With Immune Risk Factors for Postoperative Pancreatic Ductal Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05547074
• Other study ID #: PSMPDAC
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: August 31, 2022

Study information

• Verified date: September 2022
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: August 31, 2022
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Neoplasms Pancreatic

Intervention

Procedure:
• pancreatic cancer surgery
Surgical resection of pancreatic cancer,including radical or palliative surgery

Locations

Country	Name	City	State
China	First Affiliated Hospital, Medical College of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	the number of months from the date of surgery to the date of the last follow-up visit or time of death.	after pancreatic cancer surgery until october 31, 2020
Secondary	disease-free survival disease-free survival disease-free survival disease-free survival	the number of months from the date of surgery to the date of first confirmable recurrence or death	after pancreatic cancer surgery until october 31, 2020