Signature for Precise Chemosensitivity Prediction in PDAC

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital

Shanghai, 200025, China

Who can participate

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

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

Treatment and study plan

Chemotherapy

Drug

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

Primary outcomes

Overall survival

Time frame: 3-year

Time between resection and death of any cause

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2021
First posted: Jun 17, 2024
Registry last updated: Jun 17, 2024

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

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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.

Published trials that share one or more normalized conditions with this study.

Completed