Epigenomic and Machine Learning Models to Predict Pancreatic Cancer

NCT ID: NCT06334458

Last Updated: 2024-03-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-03
• Study Completion Date: 2024-12-31

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study 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)

Group Type: OTHER

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

Intervention Type: 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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Serena Oliveri

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Locations

Toulouse University Hospital

Toulouse, , France

European Institute of Oncology

Milan, , Italy

Oncological Institute "Prof. Dr. Ion Chiricuta"

Cluj-Napoca, , Romania

Catalan Institute of Oncology

Barcelona, , Spain

Countries

France; Italy; Romania; Spain

Other Identifiers

IEO 1910

Identifier Type: -

Identifier Source: org_study_id