A New Prognostic Score Model for Pancreatic Ductal Adenocarcinoma

NCT05547074 | Completed

• 1 other identifier: PSMPDAC
• Study Type: observational
• Target: 302
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms Pancreatic

Keywords

pancreatic ductal adenocarcinoma; prognostic model; tumor-infiltrating immune cell; staging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• disease-free survival disease-free survival disease-free survival disease-free survival

  after pancreatic cancer surgery until october 31, 2020

Study Arms (2)

The training cohort

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).

Procedure: pancreatic cancer surgery

The validation cohort

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).

Procedure: pancreatic cancer surgery

Interventions

pancreatic cancer surgery PROCEDURE

Surgical resection of pancreatic cancer，including radical or palliative surgery

The training cohort; The validation cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PDAC cases that underwent surgical resection (including radical or palliative surgery) from January 2016 to August 2019 were retrospectively reviewed and the survival follow-up (more than 14 months) was performed.

You may qualify if:

• Pathologically confirmed PDAC
• Achievement of surgical resection (including radical or palliative surgery)

You may not qualify if:

• Lost to follow-up
• Simultaneous presence of other tumors
• Died in three months after surgery

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

First Affiliated Hospital, Medical College of Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Tingbo Liang

  First Affiliated Hospital, Medical College of Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hepatobiliary and Pancreatic Surgery

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 21, 2022
• Study Start: September 1, 2019
• Primary Completion: October 30, 2020
• Study Completion: August 31, 2022
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)