Gene Signature Developed Using Machine Learning for Precise Prediction of Relapse and Survival in Resected Stage I-II Pancreatic Ductal Adenocarcinoma
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
Lei Huang
Research PI, Research Associate
Ruijin Hospital
