PREVENPANC Project: a Spanish Multicenter Study for Pancreatic Cancer Prevention

NCT06760741 | Not Yet Recruiting

• 1 other identifier: PREVENPANC
• Study Type: observational
• Target: 900
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatic Cancer, Adult; Hereditary Pancreatic Cancer; Familial Pancreatic Cancer

Keywords

Screening; Pancreatic cancer; High risk pancreatic cancer; Hereditary pancreatic cancer; Familial pancreatic cancer; miRNA pancreatic cancer

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Identification of Pancreatic Cancer Risk Groups within the General Population

  Until March 2026

• Identification of Pancreatic Cancer Risk Groups within the General Population

  Until March 2026

Other Outcomes (1)

• Establish a Spanish Multicenter Network for Collaborative Research on Pancreatic Cancer Prevention in Our Setting ("PREVENPANC")

  November 2025

Study Arms (3)

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.

Interventions

Multigene panel 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).

Population-based Pancreatic Cancer Cohort

Other 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.

Also known as: RMN, Blood test, Ecoendoscopia biliopancreática

Retrospective cohort

miRNA measurement in blood 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.

Retrospective cohort

Generation of 3D Pancreatic Organoids 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.

Population-based Pancreatic Cancer Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Population-Based Cohort: Prospective inclusion of all patients diagnosed with pancreatic cancer (PC) over a 12-month period at participating centers, paired with a control group of individuals without known pancreatic pathology. Controls will be matched by age, sex, and self-identified gender. 2. Retrospective Cohort (Individuals from Families with Familial Pancreatic Cancer or Hereditary Pancreatic Cancer): Observational multicenter study with retrospective inclusion of all individuals from families with familial pancreatic cancer (FPC) or hereditary pancreatic cancer (HPC) who have been under follow-up from 2014 to the present in the High Risk Digestive Cancer Clinics of the participating centers. Peripheral blood samples (serum, plasma, and DNA) from most of these individuals are currently available in biobank storage.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Hospital Universitario de Canarias: collaborator
• Hospital Universitario Marqués de Valdecilla: collaborator
• Hospital Universitario Ramon y Cajal: collaborator
• Hospital de Cruces: collaborator
• Hospital Universitario de Puerta de Hierro: collaborator
• Clinica Universidad de Navarra, Universidad de Navarra: collaborator
• Complexo Hospitalario de Ourense: collaborator

Related Publications (2)

• Llach J, Luzko I, Earl J, Barreto E, Rodriguez-Garrote M, Lleixa M, Herrera-Pariente C, Fernandez G, Munoz J, Bonjoch L, Sauri T, Ausania F, Ocana T, Moreno L, Grau E, Oriola J, Alvarez-Mora MI, Herreros-Villanueva M, Castellvi-Bel S, Balaguer F, Bujanda L, Moreira L. Should We Offer Universal Germline Genetic Testing to All Patients with Pancreatic Cancer? A Multicenter Study. Cancers (Basel). 2024 Nov 9;16(22):3779. doi: 10.3390/cancers16223779.

  PMID: 39594734 BACKGROUND

• Vila-Navarro E, Duran-Sanchon S, Vila-Casadesus M, Moreira L, Gines A, Cuatrecasas M, Lozano JJ, Bujanda L, Castells A, Gironella M. Novel Circulating miRNA Signatures for Early Detection of Pancreatic Neoplasia. Clin Transl Gastroenterol. 2019 Apr;10(4):e00029. doi: 10.14309/ctg.0000000000000029.

  PMID: 31009404 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum Plasma Pancreatic tissue

MeSH Terms

Conditions

Pancreatic cancer, adult; Pancreatic carcinoma, familial; Pancreatic Neoplasms

Interventions

Hematologic Tests; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Specimen Handling; Punctures; Surgical Procedures, Operative

Central Study Contacts

Irina Luzko

CONTACT

+34932275400; LUZKO@CLINIC.CAT

Leticia Moreira, PhD

CONTACT

lmoreira@clinic.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. Gastroenterologist. Irina Luzko

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: January 7, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 7, 2025

Record last verified: 2025-01