Study of a Polygenic Risk Score to Predict the Risk of Pancreatic Ductal Adenocarcinoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCatholic University of the Sacred Heart
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Blood sample collection
Other interventionBlood 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.
Treatment groups
1,140 Participants
are divided into 2 treatment groupsGroup A: CasesOther 1 intervention
Group B: ControlsOther 1 intervention
Trial outcomes
Primary outcomes
1
Odds of developing Pancreatic Ductal Adenocarcinoma (PDAC) according to weighted polygenic risk score (PRS) percentile categories
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.
Time frame
At baseline / study enrollmentSecondary outcomes
1
Odds of pancreatic ductal adenocarcinoma by multifactorial risk score percentile category
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.
Time frame
At baseline / study enrollment2
Distribution of demographic and clinical characteristics according to weighted polygenic risk score percentile categories in PDAC patients
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.
Time frame
At baseline / study enrollment3
Distribution of circulating biomarker levels according to weighted polygenic risk score percentile categories in PDAC patients
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.
Time frame
At baseline / study enrollment4
Distribution of treatment modalities according to weighted polygenic risk score percentile categories in PDAC patients
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.
Time frame
At baseline / study enrollmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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