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

European Institute of Oncology

Status: Active, not recruiting

Conditions: Pancreatic Cancer

Treatments: Diagnostic Test: Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups

Study type: Interventional

Funder types: Other

Identifiers

NCT06334458

IEO 1910

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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170 participants in 1 patient group

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

Other group

Description:

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

Treatment:

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