Epigenomic And Machine Learning Models To Predict Pancreatic Cancer

Study Overview

Epigenomic and Machine Learning Models to Predict Pancreatic Cancer

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. 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.

Pancreatic Cancer

DIAGNOSTIC_TEST: Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups

IEO 1910

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-03-21	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-03-21
First Submitted that Met QC Criteria 2024-03-21	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-03-28
First Posted (ACTUAL) 2024-03-28	Results First Posted N/A	Last Verified 2024-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
OTHER: Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups Early diagnosis for pancreatic cancer in first degree healthy/asymptomatic relatives of patients with exocrine pancreatic cancer (high-risk asymptomatic subject groups)	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

Participant Group/Arm

Intervention/Treatment

OTHER: Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups

Early diagnosis for pancreatic cancer in first degree healthy/asymptomatic relatives of patients with exocrine pancreatic cancer (high-risk asymptomatic subject groups)

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

Primary Outcome Measures	Measure Description	Time Frame
Observation of a two or three-fold enrichment in early detection of suspicious pancreatic lesion using the CRPA algorithm	Develop/calibrate/validate a comprehensive cancer risk prediction algorithm (CRPA) and observe a two or three-fold enrichment in early detection of suspicious pancreatic lesion in our sample of HR individuals (incidence about 24%), stratified through the application of the Machine Learning algorithm, the CRPA.	5 years
Identification of one or more abnormal methylation changes present in blood cells of participants with suspicious lesions versus methylation profiles of participants with no identified lesions	Provide evidence that the implementation of epigenetic biomarkers profiles in CRPA leads to a significant improvement of accuracy of cancer risk prediction models. This endpoint will be reached with the identification of a methylation profile referred to as a risk signature (defined as one or more abnormal methylation changes present in blood cells of participants) by analyzing blood cells methylation profiling data from participants with suspicious lesions vs methylation profiles of participants with no identified lesions;	5 years
Validation of igenetic biomarker testing in liquid biopsy followed by radiological exam as early cancer diagnostic tool	Validate whether the use of epigenetic biomarker testing in liquid biopsy followed by radiological exam can be an early cancer diagnostic tools for PC in High Risk (HR) subjects	5 years

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

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 of the following cancers: Breast cancer, Ovarian, fallopian tube or primary peritoneal cancer, Melanoma, Colorectal cancer, Endometrial cancer, Prostate cancer, Oesophagogastric cancer, Urinary tract cancer, Small bowel cancer, Brain tumour, Sebaceous skin tumour;
was confirmed diagnosis of any of the following conditions in the family: Hereditary Breast and Ovarian Cancer, Peutz-Jeghers syndrome, hereditary pancreatitis, Lynch Syndrome, Familial Atypical Multiple Mole Melanoma Syndrome;
significant family history in first degree relatives for cancer (e.g. two or more cancers in one individual or the same cancer in more individuals;
a single 1st degree relative with pancreatic cancer;
being a patient alive after 5 years from diagnosis (cancer free or currently treated).
Cancer free at the time of enrollment;

Individuals with comorbidities that adversely influence their ability to tolerate the screening procedures or the screen-detected findings, or tolerate treatment of an early- stage screen-detected cancer, or that limit their life expectancy.
Subjects already diagnosed with cancer currently in treatment;
Subjects who are already in the process of clinical assessment or included in a screening program for a suspected tumour.
Contraindications for the Whole-Body Magnetic Resonance Imaging (WB-MRI) radiological exam

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Serena Oliveri, European Institute of Oncology

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Clinical Trial Record