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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