Precise Gene Signature for Predicting Outcomes in PDAC

NCT ID: NCT05441189

Last Updated: 2022-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-19

Study Completion Date

2022-06-22

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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training cohort

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

Resection

Intervention Type PROCEDURE

radical R0 resection of pancreatic adenocarcinoma

validation cohort

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

Resection

Intervention Type PROCEDURE

radical R0 resection of pancreatic adenocarcinoma

Interventions

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Resection

radical R0 resection of pancreatic adenocarcinoma

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Fourth Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role lead

Responsible Party

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Lei Huang

Research PI, Research Associate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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PaC-SVM1

Identifier Type: -

Identifier Source: org_study_id

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