Epigenomic and Machine Learning Models to Predict Pancreatic Cancer (IMAGene)

March 21, 2024 updated by: European Institute of Oncology

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups
Early diagnosis for pancreatic cancer in first degree healthy/asymptomatic relatives of patients with exocrine pancreatic cancer (high-risk asymptomatic subject groups)
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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;
5 years
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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
European Institute of Oncology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Serena Oliveri, European Institute of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 21, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IEO 1910

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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