PREVENPANC Project: a Spanish Multicenter Study for Pancreatic Cancer Prevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-31

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Pancreatic Cancer, Adult Hereditary Pancreatic Cancer Familial Pancreatic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

Multigene panel

Intervention Type GENETIC

Germline Genetic Testing: Germline genetic testing will be performed on all patients with pancreatic cancer (PC) using a custom multigene panel. This panel includes 25 candidate genetic variants of interest and 13 clinically recognized genes associated with a higher risk of PC.

DNA Extraction: Germline DNA will be extracted from peripheral blood samples using the QIAamp DNA Blood Kit (Qiagen, Redwood City, CA, USA) following the manufacturer's instructions. The concentration of double-stranded DNA will be measured using a fluorometric method (Qubit, Thermo Fisher Scientific).

Generation of 3D Pancreatic Organoids

Intervention Type GENETIC

Generation of 3D Pancreatic Organoids for Complementary Analyses:

3D pancreatic organoids will be generated for complementary analyses involving in vitro functional studies to evaluate the pathogenicity of novel genes (selected based on the results of the multigene panel). These organoids will be developed from surgical samples obtained from five patients undergoing surgery as part of clinical care.

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.

Other

Intervention Type DIAGNOSTIC_TEST

1. Characterization of Suspected Pancreatic Cancer Lesions:

Characterization of suspected pancreatic cancer (PC) lesions identified by endoscopic ultrasound (EUS) and/or magnetic resonance imaging (MRI) in patients undergoing screening since 2014. This includes lesion type (solid or cystic), rapid cyst growth exceeding 4 mm per year, location, size, potential assessment of resectability, lobulocentric parenchymal atrophy, and Wirsung duct dilation. Clinically relevant suspected lesions will be defined as solid lesions, intraductal papillary mucinous neoplasms (IPMN), cystic lesions ≥10 mm, and cystic lesions with mural nodules.
2. Determination of CA 19-9 and Glycated Hemoglobin:

Measurement of CA 19-9 levels and glycated hemoglobin (HbA1c) as part of the diagnostic and monitoring process.

miRNA measurement in blood

Intervention Type DIAGNOSTIC_TEST

Analysis of miRNA Expression in plasma:

The expression of circulating miRNAs (in plasma) will be analyzed using quantitative reverse transcription polymerase chain reaction (qRT-PCR). The signature includes two miRNAs (miR-33a-3p and miR-320a) combined with CA 19-9.

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.

No interventions assigned to this group

Interventions

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Multigene panel

Germline Genetic Testing: Germline genetic testing will be performed on all patients with pancreatic cancer (PC) using a custom multigene panel. This panel includes 25 candidate genetic variants of interest and 13 clinically recognized genes associated with a higher risk of PC.

DNA Extraction: Germline DNA will be extracted from peripheral blood samples using the QIAamp DNA Blood Kit (Qiagen, Redwood City, CA, USA) following the manufacturer's instructions. The concentration of double-stranded DNA will be measured using a fluorometric method (Qubit, Thermo Fisher Scientific).

Intervention Type GENETIC

Other

1. Characterization of Suspected Pancreatic Cancer Lesions:

Characterization of suspected pancreatic cancer (PC) lesions identified by endoscopic ultrasound (EUS) and/or magnetic resonance imaging (MRI) in patients undergoing screening since 2014. This includes lesion type (solid or cystic), rapid cyst growth exceeding 4 mm per year, location, size, potential assessment of resectability, lobulocentric parenchymal atrophy, and Wirsung duct dilation. Clinically relevant suspected lesions will be defined as solid lesions, intraductal papillary mucinous neoplasms (IPMN), cystic lesions ≥10 mm, and cystic lesions with mural nodules.
2. Determination of CA 19-9 and Glycated Hemoglobin:

Measurement of CA 19-9 levels and glycated hemoglobin (HbA1c) as part of the diagnostic and monitoring process.

Intervention Type DIAGNOSTIC_TEST

miRNA measurement in blood

Analysis of miRNA Expression in plasma:

The expression of circulating miRNAs (in plasma) will be analyzed using quantitative reverse transcription polymerase chain reaction (qRT-PCR). The signature includes two miRNAs (miR-33a-3p and miR-320a) combined with CA 19-9.

Intervention Type DIAGNOSTIC_TEST

Generation of 3D Pancreatic Organoids

Generation of 3D Pancreatic Organoids for Complementary Analyses:

3D pancreatic organoids will be generated for complementary analyses involving in vitro functional studies to evaluate the pathogenicity of novel genes (selected based on the results of the multigene panel). These organoids will be developed from surgical samples obtained from five patients undergoing surgery as part of clinical care.

Intervention Type GENETIC

Other Intervention Names

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RMN Blood test Ecoendoscopia biliopancreática

Eligibility Criteria

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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).