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Clinical Trials/NCT05441189
NCT05441189CompletedNot Applicable

Gene Signature Developed Using Machine Learning for Precise Prediction of Relapse and Survival in Resected Stage I-II Pancreatic Ductal Adenocarcinoma

The Fourth Affiliated Hospital of Anhui Medical University1 site in 1 country70 target enrollmentStarted: April 19, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
70
Locations
1
Primary Endpoint
Overall survival

Study Overview

Brief Summary

The current TNM staging system is not sufficient for prediction of prognosis and cannot precisely identify the patients who are in greater need of adjuvant therapy in pancreatic ductal adenocarcinoma (PDAC). Tumor mutation and copy number variation (CNV) markers may have a higher predictive value. In this study, whole exosome sequencing was performed for patients with stage I-II PDAC undergoing R0 resection. The investigators aimed to identify genes with discrepant statuses of mutations or CNVs between patients with and without relapse within 1 year after R0 resection, and then to construct a support vector machine (SVM)-based prognostic classifier (the SVM signature) for PDAC using machine learning; the investigators then aimed to further validate the SVM signature in an independent cohort.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Availability of hematoxylin and eosin slides with invasive tumor components
  • Availability of clinicopathologic characteristics and follow-up data
  • No previous history of cancer

Exclusion Criteria

  • No formalin-fixed, paraffin-embedded (FFPE) tumor sample of primary tumor
  • Receipt of any neoadjuvant and/or adjuvant cancer-directed therapy
  • Survival time <3 months after resection

Outcomes

Primary Outcomes

Overall survival

Time Frame: 3-year

the time to death from any cause

Disease-free survival

Time Frame: 3-year

the time to recurrence at any site or all-cause death, whichever occurred first

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
The Fourth Affiliated Hospital of Anhui Medical University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lei Huang

Research PI, Research Associate

Ruijin Hospital

Study Sites (1)

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