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Trial Title: Epigenomic and Machine Learning Models to Predict Pancreatic Cancer

NCT ID: NCT06334458

Condition: Pancreatic Cancer

Conditions: Official terms:
Pancreatic Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups
Description: 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
Arm group label: Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Toulouse University Hospital

Address:
City: Toulouse
Country: France

Facility:
Name: European Institute of Oncology

Address:
City: Milan
Country: Italy

Facility:
Name: Oncological Institute "Prof. Dr. Ion Chiricuta"

Address:
City: Cluj-Napoca
Country: Romania

Facility:
Name: Catalan Institute of Oncology

Address:
City: Barcelona
Country: Spain

Start date: February 3, 2023

Completion date: December 31, 2024

Lead sponsor:
Agency: European Institute of Oncology
Agency class: Other

Source: European Institute of Oncology

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06334458

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