Study of a Polygenic Risk Score to Predict the Risk of Pancreatic Ductal Adenocarcinoma

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Pancreatic Ductal Adenocarcinoma (mPDAC) Digestive System Diseases Digestive System Neoplasms Disease Attributes Disease Susceptibility Endocrine Gland Neoplasms Endocrine System Diseases Genetic Predisposition to Disease Genetic Risk Score Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Sample Collection

Other

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.

Primary outcomes

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.

Secondary outcomes

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.
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.
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.
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.

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study title

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

Acronym: PRE-PDAC

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Apr 8, 2026
Registry last updated: Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting