A New Prognostic Score Model for Pancreatic Ductal Adenocarcinoma

September 20, 2022 updated by: TingBo Liang, Zhejiang University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

302

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • First Affiliated Hospital, Medical College of Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Surgical resection of pancreatic cancer，including radical or palliative 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
Surgical resection of pancreatic cancer，including radical or palliative surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 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.
after pancreatic cancer surgery until october 31, 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease-free survival disease-free survival disease-free survival disease-free survival
Time Frame: 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
after pancreatic cancer surgery until october 31, 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Investigators

  • Principal Investigator: Tingbo Liang, First Affiliated Hospital, Medical College of Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2019

Primary Completion (ACTUAL)

October 30, 2020

Study Completion (ACTUAL)

August 31, 2022

Study Registration Dates

First Submitted

September 15, 2022

First Submitted That Met QC Criteria

September 15, 2022

First Posted (ACTUAL)

September 21, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 22, 2022

Last Update Submitted That Met QC Criteria

September 20, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSMPDAC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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