Precise Gene Signature for Predicting Outcomes in PDAC

The Fourth Affiliated Hospital of Anhui Medical University

Status: Completed

Conditions: Stage I-II Pancreatic Ductal Adenocarcinoma (PDAC); Precise Prognostic and Predictive Signature

Treatments: Procedure: Resection

Study type: Observational

Funder types: Other

Identifiers

NCT05441189

PaC-SVM1

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

70 participants in 2 patient groups

training cohort

Description:

30 patients undergoing resection between March 2015 and December 2016 at Chinese PLA General Hospital in Beijing, China

Treatment:

Procedure: Resection

validation cohort

Description:

40 patients from The Cancer Genome Atlas (TCGA) database (https://www.cancer.gov/about-nci/organization/ccg/research/structural-genomics/tcga)

Treatment:

Procedure: Resection