Clinical trial · Interventional
Epigenomic and Machine Learning Models to Predict Pancreatic Cancer
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
NCT06334458CI-TRIAL-00075508IMAGeneunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups
- description
- Early diagnosis for pancreatic cancer in first degree healthy/asymptomatic relatives of patients with exocrine pancreatic cancer (high-risk asymptomatic subject groups)
- interventionNames
- Diagnostic Test: Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups
Primary outcomes (3)
- measure
- Observation of a two or three-fold enrichment in early detection of suspicious pancreatic lesion using the CRPA algorithm
- timeFrame
- 5 years
- description
- 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.
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRiobo-Mayo L, Salvador L, Teule A, Guino E, Layos L, Oliveri S, Cincidda C, Ongaro G, Accornero CA, Cella CA, Gervaso L, Fazio N, Summers PE, Petralia G, Canivet C, Bournet B, Buscail L, Roman A, Balacescu L, Trifa A, Catana A, Pop F, Balacescu O, Przybylowicz P, Taryma-Lesniak O, Wojdacz TK, Obon-Santacana M, Moreno V. Development and validation of an epidemiological risk score for early detection of pancreatic cancer in high-risk individuals within the IMAGene project. Int J Epidemiol. 2026 Apr 17;55(3):dyag064. doi: 10.1093/ije/dyag064. PMID 42160519