AzTrials
AzTrials

Pancreatic Cancer, AdultPREVENPANCNCT06760741

PREVENPANC Project: a Spanish Multicenter Study for Pancreatic Cancer Prevention

An observational study of Pancreatic Cancer, Adult and Hereditary Pancreatic Cancer, run by Hospital Clinic of Barcelona.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Multigene panel, Other and miRNA measurement in blood
How many people
900 participants
Where
No sites listed yet
Study dates
Jan 2025to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Irina Luzko contact

+34932275400

LUZKO@CLINIC.CAT

Leticia Moreira, PhD contact

lmoreira@clinic.cat

About this study

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.

Read more

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.

Being tested
Multigene panel, Other, miRNA measurement in blood, Generation of 3D Pancreatic Organoids
Keywords
Screening, Pancreatic cancer, High risk pancreatic cancer, Hereditary pancreatic cancer, Familial pancreatic cancer, miRNA pancreatic cancer
Medical subject headings
Pancreatic cancer, adult, Pancreatic carcinoma, familial, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multigene panelGenetic

    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).

  • OtherDiagnostic test

    Also called RMN, Blood test, Ecoendoscopia biliopancreática

    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 bloodDiagnostic 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.

  • Generation of 3D Pancreatic OrganoidsGenetic

    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.

Study groups in NCT06760741
Study groupRoleWhat they receive
Population-based Pancreatic Cancer CohortPROSPECTIVE COHORT: Prospective inclusion of all patients from the general population diagnosed with pancreatic cancer over one year in each center.
Receives: 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.
Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identification of Pancreatic Cancer Risk Groups within the General Population

    *Clinical Protocol:

    • Identify the factors and risk groups globally associated with pancreatic cancer (PC).

    Measured: Until March 2026

  2. 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.

    Measured: Until March 2026

  3. 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.

    Measured: Until March 2026

  4. 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).

    Measured: Until October 2026

  5. Evaluate Screening Strategies in High-Risk Individuals

    *Clinical Protocol:

    -Determine the prevalence of PC in families diagnosed with FPC and HPC in our setting.

    Measured: Until October 2026

  6. Evaluate Screening Strategies in High-Risk Individuals

    *Clinical Protocol:

    • Assess the efficacy of PC screening strategies in these high-risk groups (FPC and HPC).

    Measured: Until October 2026

  7. 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.

    Measured: Until October 2026

Secondary outcomes (2)
  1. 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.

    Measured: Until March 2026

  2. 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.

    Measured: Until March 2026

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2025
  2. Study startJan 2025 (estimated)
  3. Primary completionNov 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06760741
Sponsor's protocol ID
PREVENPANC
Acronym
PREVENPANC
Status last verified
Jan 2025
First submitted
18 Dec 2024
Last updated
7 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 39594734
  • 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.

    PubMed 31009404

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatic Cancer, Adult and Hereditary Pancreatic Cancer, run by Hospital Clinic of Barcelona.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Irina Luzko (+34932275400, LUZKO@CLINIC.CAT), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identification of Pancreatic Cancer Risk Groups within the General Population (time frame: Until March 2026). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06760741, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in