Pancreatic Ductal Adenocarcinoma (mPDAC)PRE-PDACNCT07516392
Study of a Polygenic Risk Score to Predict the Risk of Pancreatic Ductal Adenocarcinoma
A study testing Blood sample collection in people with Pancreatic Ductal Adenocarcinoma (mPDAC), run by Catholic University of the Sacred Heart.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (mPDAC)
- What is being tested?
- Blood sample collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,140 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: PRE-PDAC: Evaluation of Polygenic Risk scorE for Pancreatic Ductal AdenoCarcinoma Risk Prediction: a Case-control Study
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.
- Conditions
- Pancreatic Ductal Adenocarcinoma (mPDAC)
- Being tested
- Blood sample collection
- Keywords
- Pancreatic Cancer, polygenic risk score, PRS, pancreatic ductal adenocarcinoma, case-control study, risk prediction, genetic susceptibility, pancreatic neoplasms
- Medical subject headings
- Pancreatic Neoplasms, Genetic Risk Score, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline / study enrollment
Secondary outcomes (4)
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.
Measured: At baseline / study enrollment
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.
Measured: 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.
Measured: 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.
Measured: At baseline / study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal Adenocarcinoma (mPDAC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefania Boccia, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516392
- Sponsor's protocol ID
- 7370
- Acronym
- PRE-PDAC
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRE-PDAC: Evaluation of Polygenic Risk scorE for Pancreatic Ductal AdenoCarcinoma Risk Prediction: a Case-control Study
- ClinicalTrials.gov ID
- NCT07516392
- Acronym / sponsor ID
- PRE-PDAC / 7370
- Conditions
- Pancreatic Ductal Adenocarcinoma (mPDAC)
- Keywords
- Pancreatic Cancer, polygenic risk score, PRS, pancreatic ductal adenocarcinoma, case-control study, risk prediction, genetic susceptibility, pancreatic neoplasms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,140 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | Other | Other: Blood sample collectionParticipants 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 | Other: Blood sample collectionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collectionBlood 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. | Other | Cases, Controls |
Primary outcome
Odds of developing Pancreatic Ductal Adenocarcinoma (PDAC) according to weighted polygenic risk score (PRS) percentile categories
Time frame: 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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample collection in people with Pancreatic Ductal Adenocarcinoma (mPDAC), run by Catholic University of the Sacred Heart.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Odds of developing Pancreatic Ductal Adenocarcinoma (PDAC) according to weighted polygenic risk score (PRS) percentile categories (time frame: At baseline / study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.