PREVENPANC Project: a Spanish Multicenter Study for Pancreatic Cancer Prevention

Not yet recruiting

• Conditions: Pancreatic Cancer, Adult; Familial Pancreatic Cancer; Hereditary Pancreatic Cancer

• Registration Number: NCT06760741
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-18
• Status Verified: 2025-01
• Study Start: 2025-01
• Study First Submitted QC: 2025-01-03
• Last Update Submitted: 2025-01-03
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07
• Primary Completion: 2026-11
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

• Patients with a recent diagnosis of pancreatic cancer in the general population.
• High-risk individuals under follow-up in high-risk clinics (hereditary syndromes, familial pancreatic cancer).

Exclusion Criteria

• Patients under 18 years old.
• Patients who have undergone treatment for pancreatic cancer.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of Pancreatic Cancer Risk Groups within the General Population	Until March 2026	\*Translational Protocol: - Discover and validate new hereditary genes associated with an increased risk of PC through targeted sequencing using a multigene panel.
Evaluate Screening Strategies in High-Risk Individuals	Until October 2026	\*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.

Secondary Outcome Measures

Name	Time	Method
Identification of Pancreatic Cancer Risk Groups within the General Population	Until March 2026	\*Translational Protocol: - Evaluate the pathogenicity of identified genetic variants through in vitro functional studies using the generation and modification of 3D pancreatic organoids.