Epigenomic and Machine Learning Models to Predict Pancreatic Cancer

Not Applicable

Active, not recruiting

• Conditions: Pancreatic Cancer
• Interventions: Diagnostic Test: Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups

• Registration Number: NCT06334458
• Lead Sponsor: European Institute of Oncology

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.

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 Timeline

• Study Start: 2023-02-03
• Primary Completion: 2024-02-21
• Status Verified: 2024-03
• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-21
• Last Update Submitted: 2024-03-21
• Study First Posted: 2024-03-28
• Last Update Posted: 2024-03-28
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 170

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups	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)

Primary Outcome Measures

Name	Time	Method
Observation of a two or three-fold enrichment in early detection of suspicious pancreatic lesion using the CRPA algorithm	5 years	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.
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	5 years	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;
Validation of igenetic biomarker testing in liquid biopsy followed by radiological exam as early cancer diagnostic tool	5 years	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

Trial Locations

Locations (4)

European Institute of Oncology; 🇮🇹 Milan, Italy

Catalan Institute of Oncology; 🇪🇸 Barcelona, Spain

Oncological Institute "Prof. Dr. Ion Chiricuta"; 🇷🇴 Cluj-Napoca, Romania

Toulouse University Hospital; 🇫🇷 Toulouse, France