Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334458
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-21
Brief Title:
Epigenomic and Machine Learning Models to Predict Pancreatic Cancer
Sponsor:
European Institute of Oncology
Organization:
European Institute of Oncology
Study Overview
Official Title:
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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMAGene
Brief 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
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 healthyasymptomatic 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
The study population consists of 170 first 1st degree healthyasymptomatic 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None