Clinical trial NCT06334458: Epigenomic and Machine Learning Models to Predict Pancreatic Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Observation of a two or three-fold enrichment in early detection of suspicious pancreatic lesion using the CRPA algorithm
timeFrame: 5 years
measure: 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
timeFrame: 5 years
measure: Validation of igenetic biomarker testing in liquid biopsy followed by radiological exam as early cancer diagnostic tool
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Toulouse University Hospital
city: Milan
country: Italy
facility: European Institute of Oncology
city: Cluj-Napoca
country: Romania
facility: Oncological Institute "Prof. Dr. Ion Chiricuta"
city: Barcelona
country: Spain
facility: Catalan Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Serena Oliveri
role: PRINCIPAL_INVESTIGATOR
References: