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Precise Gene Signature for Predicting Outcomes in PDAC

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05441189
Enrollment
70
Registered
2022-07-01
Start date
2021-04-19
Completion date
2022-06-22
Last updated
2022-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDUREResection

radical R0 resection of pancreatic adenocarcinoma

Sponsors

The Fourth Affiliated Hospital of Anhui Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Disease-free survival3-yearthe time to recurrence at any site or all-cause death, whichever occurred first
Overall survival3-yearthe time to death from any cause

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026