A New Prognostic Score Model for Pancreatic Ductal Adenocarcinoma

Sponsor

Zhejiang University (Other)

Overall Status

Completed

CT.gov ID

NCT05547074

Collaborator

(none)

302

Enrollment

Location

Actual Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms Pancreatic	Procedure: pancreatic cancer surgery

Study Design

Study Type:

Observational

Actual Enrollment :

302 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2019

Actual Primary Completion Date :

Oct 30, 2020

Actual Study Completion Date :

Aug 31, 2022

Arms and Interventions

Arm	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

Arm

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

Procedure: pancreatic cancer surgery

Surgical resection of pancreatic cancer，including radical or palliative surgery

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital, Medical College of Zhejiang University	Hangzhou	Zhejiang	China	310003

Sponsors and Collaborators

Zhejiang University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

TingBo Liang, Head of Hepatobiliary and Pancreatic Surgery, Zhejiang University

ClinicalTrials.gov Identifier:

NCT05547074

Other Study ID Numbers:

PSMPDAC

First Posted:

Sep 21, 2022

Last Update Posted:

Sep 22, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by TingBo Liang, Head of Hepatobiliary and Pancreatic Surgery, Zhejiang University

pancreatic ductal adenocarcinoma

prognostic model

tumor-infiltrating immune cell

staging

Additional relevant MeSH terms:

Adenocarcinoma

Study Results

No Results Posted as of Sep 22, 2022