NCT07516392

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,140

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Apr 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Apr 2026Sep 2026

First Submitted

Initial submission to the registry

March 18, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

April 8, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

March 18, 2026

Last Update Submit

March 30, 2026

Conditions

Pancreatic Ductal Adenocarcinoma (mPDAC)

Keywords

Pancreatic Cancerpolygenic risk scorePRSpancreatic ductal adenocarcinomacase-control studyrisk predictiongenetic susceptibilitypancreatic neoplasms

Outcome Measures

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.

    At baseline / study enrollment

Secondary Outcomes (4)

  • Odds of pancreatic ductal adenocarcinoma by multifactorial risk score percentile category

    At baseline / study enrollment

  • Distribution of demographic and clinical characteristics according to weighted polygenic risk score percentile categories in PDAC patients

    At baseline / study enrollment

  • Distribution of circulating biomarker levels according to weighted polygenic risk score percentile categories in PDAC patients

    At baseline / study enrollment

  • Distribution of treatment modalities according to weighted polygenic risk score percentile categories in PDAC patients

    At baseline / study enrollment

Study Arms (2)

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.

Other: Blood sample collection

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.

Other: Blood sample collection

Interventions

Blood sample collectionOTHER

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.

CasesControls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Age younger than 18 years.
  • Inability to provide informed consent.
  • Incomplete or unavailable clinical and/or biological data required for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatic NeoplasmsGenetic Risk ScoreGenetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesDisease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

March 18, 2026

First Posted

April 8, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

April 8, 2026

Record last verified: 2026-03