NCT06334458

Epigenomic and Machine Learning Models to Predict Pancreatic Cancer

Development of a New Algorithm to Integrate Clinical, Omics, DNA Methylation Biomarkers and Epidemiological Data for Early Detection of Pancreatic Cancer in High-risk Individuals

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of the multicentric and interdisciplinary IMAGene project is to pursue early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups, by developing and validating a comprehensive cancer risk prediction algorithm (CRPA) as a clinical support tool to calculate a personalized risk profile. The study is a longitudinal, non-randomized exploratory clinical study. A total of 170 asymptomatic first-degree relatives of PC patients.

Detailed description

The study is a longitudinal, non-randomized exploratory clinical study. A total of 170 asymptomatic first-degree relatives of PC patients. The study population consists of 170 first (1st) degree healthy/asymptomatic relatives of patients with exocrine pancreatic cancer, where the patient satisfies one OR more of the following conditions: * was diagnosed with pancreatobiliary cancer \<50 years of age; * was diagnosed with pancreatobiliary cancer \>50 years of age AND personal history of any solid cancers. The CRPA will be assessed in 170 first degree relatives of PC patients, in whom the development of pancreatic cysts will be assessed by WB-MRI at baseline and at one year.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups	Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups by developing and validating a comprehensive cancer risk prediction algorithm (CRPA) as a clinical support tool to calculate a personalized risk profile

Timeline

• Start date: 2023-02-03
• Primary completion: 2024-02-21
• Completion: 2024-12-31
• First posted: 2024-03-28
• Last updated: 2024-03-28

Locations

4 sites across 4 countries: France, Italy, Romania, Spain