Pancreatic Ductal Adenocarcinoma (mPDAC)
Conditions
Keywords
Pancreatic Cancer, polygenic risk score, PRS, pancreatic ductal adenocarcinoma, case-control study, risk prediction, genetic susceptibility, pancreatic neoplasms
Brief summary
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
OTHERBlood 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.
Sponsors
Catholic University of the Sacred Heart
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Odds of developing Pancreatic Ductal Adenocarcinoma (PDAC) according to weighted polygenic risk score (PRS) percentile categories | 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
| Measure | Time frame | Description |
|---|---|---|
| Odds of pancreatic ductal adenocarcinoma by multifactorial risk score percentile category | 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 | 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 | 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 | 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. |
Outcome results
None listed