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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | Other | 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. |
|
| Controls | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline / study enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline / study enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 18, 2025 | Mar 25, 2026 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed consent for perspective controls | Dec 18, 2025 | Mar 18, 2026 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed consent for cases | Apr 16, 2025 | Mar 18, 2026 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed consent for retrospective controls | Dec 18, 2025 | Mar 18, 2026 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D000096442 | Genetic Risk Score |
| D020022 | Genetic Predisposition to Disease |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| 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. | At baseline / study enrollment |
| 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. | At baseline / study enrollment |
| 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. | At baseline / study enrollment |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |