Epigenomic and Machine Learning Models to Predict Pancreatic Cancer (IMAGene)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Diagnostic test: Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups

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.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France
    • Toulouse University Hospital
• Italy
  • Milan, Italy
    • European Institute of Oncology
• Romania
  • Cluj-Napoca, Romania
    • Oncological Institute "Prof. Dr. Ion Chiricuta"
• Spain
  • Barcelona, Spain
    • Catalan Institute of Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Serena Oliveri, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2023
• Primary Completion (Actual): February 21, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: IEO 1910

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No