Epigenomic and Machine Learning Models to Predict Pancreatic Cancer

NCT06334458 | Active Not Recruiting

• 1 other identifier: IEO 1910
• Study Type: interventional
• Target: 170
• Locations: 4 countries
• Sites: 4

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

OTHER

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

Interventions

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

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• st 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (4)

Toulouse University Hospital

Toulouse, France

Location

European Institute of Oncology

Milan, Italy

Location

Oncological Institute "Prof. Dr. Ion Chiricuta"

Cluj-Napoca, Romania

Location

Catalan Institute of Oncology

Barcelona, Spain

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Early Diagnosis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnosis

Study Officials

• Serena Oliveri

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: February 3, 2023
• Primary Completion: February 21, 2024
• Study Completion: December 31, 2024
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

IT (1); RO (1); FR (1); ES (1)