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NCT06461598 Clinical Trial

Signature for Precise Chemosensitivity Prediction in PDAC

Pancreatic Cancer Clinical Trial

Official title:
Development and Validation of the ChemoResist Signature Precisely Predictive of Chemotherapy Sensitivity in Resected Pancreatic Ductal Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06461598
Other study ID # ChemoResist-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date May 31, 2021

Study information
Verified date June 2024
Source Ruijin Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pancreatic ductal adenocarcinoma (PDAC) is largely heterogeneous. We sought to develop and validate a signature to precisely predict chemotherapy sensitivity in PDAC. Genetic events of the four most commonly mutated genes in PDAC and expressions of 12 PI3K/AKT/mTOR pathway markers were examined in consecutive patients with PDAC. A 9-feature signature for prediction of chemotherapy benefits was constructed using the LASSO Cox regression model, and validated in two independent cohorts.

Recruitment information / eligibility
Status Completed
Enrollment 365
Est. completion date May 31, 2021
Est. primary completion date March 16, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - ECOG performance status score of 0-1 before resection - complete clinicopathologic and follow-up data - availability of formalin-fixed paraffin-embedded (FFPE) specimens of resected primary tumor and hematoxylin and eosin slides with invasive tumor components Exclusion Criteria: - any previous history of cancer - any anticancer therapy prior to resection or adjuvant radiotherapy - metastatic cases - major postsurgical complications with Clavien-Dindo Grade =2

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Chemotherapy
All adjuvant chemotherapy for nonmetastatic PDAC was gemcitabine-based (Cycle >= 1).

Locations
Country Name City State
China Ruijin Hospital Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival Time between resection and death of any cause 3-year
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