Study of a Polygenic Risk Score to Predict the Risk of Pancreatic Ductal Adenocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sample collection.
- Who it may be relevant to
- Registry conditions: Pancreatic Ductal Adenocarcinoma (mPDAC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
PRE-PDAC: Evaluation of Polygenic Risk scorE for Pancreatic Ductal AdenoCarcinoma Risk Prediction: a Case-control Study
Overview
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.
Interventions
- 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.
Primary outcome measures
- Odds of developing Pancreatic Ductal Adenocarcinoma (PDAC) according to weighted polygenic risk score (PRS) percentile categories [Time frame: At baseline / study enrollment]
Secondary outcome measures (4)
- Odds of pancreatic ductal adenocarcinoma by multifactorial risk score percentile category [Time frame: 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]
- Distribution of circulating biomarker levels according to weighted polygenic risk score percentile categories in PDAC patients [Time frame: 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07516392 · 7370