Precise Gene Signature for Predicting Outcomes in PDAC

NCT05441189 | Completed

• 1 other identifier: PaC-SVM1
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Disease-free survival

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

  3-year

• Overall survival

  the time to death from any cause

  3-year

Study Arms (2)

training cohort

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

Procedure: Resection

validation cohort

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

Procedure: Resection

Interventions

Resection PROCEDURE

radical R0 resection of pancreatic adenocarcinoma

training cohort; validation cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators enrolled two independent cohorts of consecutive patients with incident, primary, microscopically-confirmed stage I-II PDAC undergoing radical R0 resection only. For the training cohort, data were retrieved for 30 patients undergoing resection between March 2015 and December 2016 at Chinese PLA General Hospital in Beijing, China. Patients who did not relapse or die within 1 year after resection had follow-up of at least 1 year. The investigators also included 40 patients from The Cancer Genome Atlas (TCGA) database (https://www.cancer.gov/about-nci/organization/ccg/research/structural-genomics/tcga) as the validation cohort, with the same criteria as above; they were diagnosed between January 2010 and December 2013.

You may qualify if:

• Availability of hematoxylin and eosin slides with invasive tumor components
• Availability of clinicopathologic characteristics and follow-up data
• No previous history of cancer

You may not qualify if:

• 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

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Anhui Medical University: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research PI, Research Associate

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 1, 2022
• Study Start: April 19, 2021
• Primary Completion: May 1, 2022
• Study Completion: June 22, 2022
• Last Updated: July 7, 2022

Record last verified: 2022-07

Locations

CN (1)