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Completed

NCT Number: NCT05441189

Precise Gene Signature for Predicting Outcomes in PDAC

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resection

Procedure

radical R0 resection of pancreatic adenocarcinoma

Primary outcomes

  1. Disease-free survival

    Time frame: 3-year

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

  2. Overall survival

    Time frame: 3-year

    the time to death from any cause

Sponsors and collaborators

Lead sponsor

The Fourth Affiliated Hospital of Anhui Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 1, 2022
Registry last updated
Jul 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.