Pancreatic CancerIMAGeneNCT06334458
Epigenomic and Machine Learning Models to Predict Pancreatic Cancer
A study testing Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups in people with Pancreatic Cancer, run by European Institute of Oncology at 4 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 3 Feb 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
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
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.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groupsDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups | Other | Early diagnosis for pancreatic cancer in first degree healthy/asymptomatic relatives of patients with exocrine pancreatic cancer (high-risk asymptomatic subject groups) Receives: Diagnostic Test: Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
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;
Measured: 5 years
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start3 Feb 2023
- Primary completion21 Feb 2024
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serena Oliveri, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334458
- Sponsor's protocol ID
- IEO 1910
- Acronym
- IMAGene
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Riobo-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.
PubMed 42160519
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06334458
- Acronym / sponsor ID
- IMAGene / IEO 1910
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (actual)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups | Other | Diagnostic Test: Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groupsEarly diagnosis for pancreatic cancer in first degree healthy/asymptomatic relatives of patients with exocrine pancreatic cancer (high-risk asymptomatic subject groups) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1st degree healthy/asymptomatic relatives of patients with exocrine pancreatic cancer, where the patient satisfies one OR more of the following conditions:
- Cancer free at the time of enrollment;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groupsEarly 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 | Diagnostic test | Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups |
Primary outcome
Observation of a two or three-fold enrichment in early detection of suspicious pancreatic lesion using the CRPA algorithm
Time frame: 5 years
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.
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
Time frame: 5 years
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;
Validation of igenetic biomarker testing in liquid biopsy followed by radiological exam as early cancer diagnostic tool
Time frame: 5 years
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Derived from this study: PubMed 42160519Riobo-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serena Oliveri principal investigator
European Institute of Oncology
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups in people with Pancreatic Cancer, run by European Institute of Oncology at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Italy, Romania, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observation of a two or three-fold enrichment in early detection of suspicious pancreatic lesion using the CRPA algorithm (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06334458, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.