Epigenomic and Machine Learning Models to Predict Pancreatic Cancer

Pancreatic Cancer Clinical Trial

— IMAGene  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06334458
• Other study ID #: IEO 1910
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 3, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: European Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 170
• Est. completion date: December 31, 2024
• Est. primary completion date: February 21, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
France	Toulouse University Hospital	Toulouse
Italy	European Institute of Oncology	Milan
Romania	Oncological Institute "Prof. Dr. Ion Chiricuta"	Cluj-Napoca
Spain	Catalan Institute of Oncology	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Countries where clinical trial is conducted

France,  Italy,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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