Study of a Polygenic Risk Score to Predict the Risk of Pancreatic Ductal Adenocarcinoma (PRE-PDAC)

March 30, 2026 updated by: Stefania Boccia, Catholic University of the Sacred Heart

PRE-PDAC: Evaluation of Polygenic Risk scorE for Pancreatic Ductal AdenoCarcinoma Risk Prediction: a Case-control Study

This case-control study aims to evaluate the role of a polygenic risk score in predicting the risk of pancreatic ductal adenocarcinoma (PDAC). The study will compare genetic risk profiles between individuals with PDAC and controls without the disease in order to assess whether a polygenic risk score may help identify individuals at higher risk. The findings may contribute to improving risk stratification and supporting future strategies for early identification and prevention of pancreatic cancer.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1140

Phase

  • Not Applicable

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults aged 18 years and older.
  • Able and willing to provide informed consent.
  • For cases: participants with pancreatic ductal adenocarcinoma.
  • For controls: participants without pancreatic ductal adenocarcinoma.
  • Availability of the clinical and/or biological data required for the study, including data necessary for polygenic risk score evaluation.

Exclusion Criteria:

  • Age younger than 18 years.
  • Inability to provide informed consent.
  • Incomplete or unavailable clinical and/or biological data required for the study.
  • Any condition that, in the judgment of the investigators, makes the participant unsuitable for inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cases
Participants with pancreatic ductal adenocarcinoma (PDAC) enrolled in the study. Participants provide clinical, epidemiological, and biospecimen data for assessment of polygenic risk score performance and evaluation of risk prediction models for PDAC.
Other: Blood sample collection
Blood sample collection for biomarker and genetic analysis. Peripheral blood samples are collected from participants and used for laboratory analyses, including genotyping, biomarker assessment, and evaluation of polygenic risk score-based models for pancreatic ductal adenocarcinoma risk prediction.
Other: Controls
Participants without pancreatic ductal adenocarcinoma enrolled as controls. Participants provide clinical, epidemiological, and biospecimen data for comparison with PDAC cases and for assessment of polygenic risk score performance and PDAC risk prediction models.
Other: Blood sample collection
Blood sample collection for biomarker and genetic analysis. Peripheral blood samples are collected from participants and used for laboratory analyses, including genotyping, biomarker assessment, and evaluation of polygenic risk score-based models for pancreatic ductal adenocarcinoma risk prediction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Odds of developing Pancreatic Ductal Adenocarcinoma (PDAC) according to weighted polygenic risk score (PRS) percentile categories
Time Frame: At baseline / study enrollment
Odds ratios (ORs) with 95% confidence intervals for pancreatic ductal adenocarcinoma (PDAC) will be estimated by comparing cases and controls across weighted polygenic risk score (PRS) percentile categories using logistic regression. The 40th-60th percentile category will be used as the reference group. Analyses will be adjusted for age and sex.
At baseline / study enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Odds of pancreatic ductal adenocarcinoma by multifactorial risk score percentile category
Time Frame: At baseline / study enrollment
Odds ratios (ORs) with 95% confidence intervals for pancreatic ductal adenocarcinoma (PDAC) will be estimated across categories of the multifactorial risk score, which includes weighted polygenic risk score (PRS), smoking status, and diabetes, using logistic regression.
At baseline / study enrollment
Distribution of demographic and clinical characteristics according to weighted polygenic risk score percentile categories in PDAC patients
Time Frame: At baseline / study enrollment
The frequency distribution of age, sex, tumor stage and primary tumor localization (head versus body-tail) will be described across weighted polygenic risk score (PRS) percentile categories among PDAC cases. Differences across PRS percentile categories will be assessed using appropriate statistical tests and regression models.
At baseline / study enrollment
Distribution of circulating biomarker levels according to weighted polygenic risk score percentile categories in PDAC patients
Time Frame: At baseline / study enrollment
The distribution of circulating CA19-9 and interleukin-6 (IL-6) levels will be described across weighted polygenic risk score (PRS) percentile categories among PDAC cases. Differences across PRS percentile categories will be assessed using appropriate statistical tests and regression models.
At baseline / study enrollment
Distribution of treatment modalities according to weighted polygenic risk score percentile categories in PDAC patients
Time Frame: At baseline / study enrollment
The frequency distribution of treatment modalities, including surgery, chemotherapy, radiotherapy, and endoscopic ultrasound (EUS)-guided ablative therapy, will be described across weighted polygenic risk score (PRS) percentile categories among PDAC cases. Differences across PRS percentile categories will be assessed using appropriate statistical tests and regression models.
At baseline / study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Study record dates

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 Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7370

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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