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2025-01
2026-11
2026-12
900
NCT06760741
Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
OBSERVATIONAL
PREVENPANC Project: a Spanish Multicenter Study for Pancreatic Cancer Prevention
Background: Pancreatic cancer (PC) is an aggressive cancer with only a 7% 5-year survival rate, primarily due to late-stage diagnosis. In Spain, its incidence is rising, and by 2030, it is expected to become the second leading cause of cancer-related death worldwide. Approximately 3% of PCs occur in the context of hereditary pancreatic cancer (HPC) predisposition syndromes. Studies have shown that up to 40% of genetic mutations associated with PC in individuals under 60 years old would not have been identified using traditional clinical criteria for genetic testing. Presymptomatic genetic testing is recommended for relatives of patients with hereditary syndromes to identify those at higher risk of PC and to include them in screening programs to alter the natural history of the disease. However, there is no robust evidence supporting the best tool for early diagnosis in at-risk individuals. Currently, screening relies on endoscopic ultrasound or magnetic resonance imaging, which yield suboptimal results. Aims: By studying the clinical, molecular, and genetic characteristics of PC patients and their families, this project aims to identify factors conferring higher PC risk and to adopt preventive measures while evaluating the efficacy of current screening strategies. Additionally, the project includes a traslational subproject to identify new hereditary genes associated with increased PC risk and novel molecules (biomarkers, specifically miRNAs) with diagnostic potential. These biomarkers could serve as non-invasive tools to identify individuals at increased risk of PC through blood tests, enabling preventive measures or early diagnosis. Given the low incidence of PC (albeit with high mortality), collaborative studies are essential to achieve meaningful results. The current project represents the first Spanish multicenter population-based registry for PC, integrating clinical data and biological sample collection alongside a control group. Its goal is to prevent PC and foster collaboration between basic research and clinical application in Spain within a proven collaborative framework. Establishing the best strategy to detect high-risk individuals for PC within the general population. Identifying new PC risk genes to expand the identification of at-risk individuals. Determining effective prevention strategies for high-risk individuals. Creating a national network, "PREVENPANC," for collaborative PC research, including the collection of biological samples (blood) from all enrolled patients.
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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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-12-18 | N/A | 2025-01-03 |
2025-01-03 | N/A | 2025-01-07 |
2025-01-07 | N/A | 2025-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Population-based Pancreatic Cancer Cohort PROSPECTIVE COHORT: Prospective inclusion of all patients from the general population diagnosed with pancreatic cancer over one year in each center. | GENETIC: Multigene panel
GENETIC: Generation of 3D Pancreatic Organoids
|
| : Retrospective cohort *RETROSPECTIVE COHORT: Enrollment of individuals from families with familial or hereditary pancreatic cancer who have been under follow-up since 2014 by the High Risk Digestive Cancer Clinic of the centers and who agree to participate in the study. | DIAGNOSTIC_TEST: Other
DIAGNOSTIC_TEST: miRNA measurement in blood
|
| : Healthy control cohort *HEALTHY CONTROLS: Enrolled from general gastroenterology consultations with imaging tests performed as part of routine clinical practice that rule out pancreatic pathology. |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Identification of Pancreatic Cancer Risk Groups within the General Population | *Clinical Protocol: - Identify the factors and risk groups globally associated with pancreatic cancer (PC). | Until March 2026 |
| Identification of Pancreatic Cancer Risk Groups within the General Population | *Clinical Protocol: - Determine the prevalence of germline genetic mutations in individuals diagnosed with PC within the population-based cohort over one year. | Until March 2026 |
| Identification of Pancreatic Cancer Risk Groups within the General Population | *Translational Protocol: - Discover and validate new hereditary genes associated with an increased risk of PC through targeted sequencing using a multigene panel. | Until March 2026 |
| Evaluate Screening Strategies in High-Risk Individuals | *Clinical Protocol: -Identify specific risk factors associated with pancreatic cancer (PC) in families with familial pancreatic cancer (FPC) or hereditary pancreatic cancer (HPC). | Until October 2026 |
| Evaluate Screening Strategies in High-Risk Individuals | *Clinical Protocol: -Determine the prevalence of PC in families diagnosed with FPC and HPC in our setting. | Until October 2026 |
| Evaluate Screening Strategies in High-Risk Individuals | *Clinical Protocol: - Assess the efficacy of PC screening strategies in these high-risk groups (FPC and HPC). | Until October 2026 |
| Evaluate Screening Strategies in High-Risk Individuals | *Translational Protocol: -Evaluate the non-invasive diagnostic yield of selected mentioned miRNAs as biomarkers for PC screening and early diagnosis in FPC and HPC groups using qRT-PCR. | Until October 2026 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Identification of Pancreatic Cancer Risk Groups within the General Population | *Clinical Protocol: - Establish the most effective strategy for identifying individuals with a hereditary predisposition to PC. | Until March 2026 |
| Identification of Pancreatic Cancer Risk Groups within the General Population | *Translational Protocol: - Evaluate the pathogenicity of identified genetic variants through in vitro functional studies using the generation and modification of 3D pancreatic organoids. | Until March 2026 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Irina Luzko Phone Number: +34932275400 Email: LUZKO@CLINIC.CAT |
Study Contact Backup Name: Leticia Moreira, PhD Phone Number: Email: lmoreira@clinic.cat |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
