Pancreatic AdenocarcinomaNCT05973331
Prospective Validation of an EHR-based Pancreatic Cancer Risk Model
An observational study of Pancreatic Adenocarcinoma and Predictive Cancer Model, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The goal of this prospective observational cohort study is to validate a previously developed pancreatic cancer risk prediction algorith (the PRISM model) using electronic health records from the general population. Read more about this study
- Who is it for?
- Ages 40 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Adenocarcinoma, Predictive Cancer Model
- What is being tested?
- Pancreatic Cancer Risk Model (PRISM)
- How many people
- 6,134,060 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2023to Apr 2028
- Phase
- Observational
- 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 40 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The cohort will be selected from 44 eligible HCOs comprised of community hospitals, outpatient clinics and academic medical centers from across the US.
Who may be able to join
- Male and females age >= 40 years from 44 US HCOs from the TriNetX platform
- at least 2 clinical encounters to the HCO, within the last year, before the study start date
Who cannot join
- Personal history of PDAC or current PDAC
- Age below 40
- Notes on sampling method: no sampling was performed. All eligible individuals are included in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
About this study
Official title: Prospective Validation of an EHR-based Model to Predict Pancreatic Cancer Risk Using Multicenter US Data
The goal of this prospective observational cohort study is to validate a previously developed pancreatic cancer risk prediction algorith (the PRISM model) using electronic health records from the general population. The main questions it aims to answer are:
- Will a pancreatic cancer risk model, developed on routine EHR data, reliably and accurately predict pancreatic cancer in real-time?
- What is the average time from model deployment and risk prediction, to the date of pancreatic cancer development and what is the stage of pancreatic cancer at diagnosis? The risk model will be deployed on data from individuals eligible for the study. Each individual will be assigned a risk score and tracked over time to assess the model's discriminatory performance and calibration.
Read the detailed description
To prospectively validate, implement in real-time, and assess performance of an EHR- based PDAC risk-prediction model. To test the hypothesis that our model will reliably predict PDAC in a real-time clinical setting, we will conduct a multi-center prospective cohort study, deploying the PDAC risk model within the TriNetX federated network database, and will take the following steps:
- generate a risk prediction score for each individual under the care of 44 health care organizations (HCOs) in the USA ii) follow all individuals for up to 3 years to assess the primary end-point of PDAC development.
The following metrics will be used to test the discriminative performance and calibration of the EHR-based PDAC risk model in predicting incident PDAC, at the end of the 3-year period:
- AUROC, sensitivity, specificity, PPV/NPV for assessing discrimination
- Calibration: for assessing the accuracy of estimates, based on the estimated to observed number of events
- Conditions
- Pancreatic Adenocarcinoma, Predictive Cancer Model
- Being tested
- Pancreatic Cancer Risk Model (PRISM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic Cancer Risk Model (PRISM)Other
A neural network model (PrismNN) and a logistic regression model (PrismLR) that use routinely collected EHR data to stratify individuals from the general population into PDAC risk groups
| Study group | Role | What they receive |
|---|---|---|
| prospective general opulation cohort | Males and females age >= 40 years, without a personal history of PDAC or current PDAC, with at least 2 clinical encounters to the HCO within the year prior to the study start date. Receives: Other: Pancreatic Cancer Risk Model (PRISM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified
To assess the discriminatory performance of PRISM for prospective identification of high-risk individuals for PDAC development. ROCs and AUROC numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location.
Measured: 6 months from index date
Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified
To assess the discriminatory performance of PRISM for prospective identification of high-risk individuals for PDAC development. ROCs and AUROC numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location.
Measured: at 1 year
Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified
To assess the discriminatory performance of PRISM for prospective identification of high-risk individuals for PDAC development. ROCs and AUROC numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location.
Measured: at 2 years
Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified
To assess the discriminatory performance of PRISM for prospective identification of high-risk individuals for PDAC development. ROCs and AUROC numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location.
Measured: at 3 years
Calibration of PRISM for all groups stratified
To access how well the risk prediction by PRISM aligns with observed risk without recalibration. Calibration plots will be created for the whole population and groups stratified by age, sex, race, and geographical location.
Measured: 6 months from index date
Calibration of PRISM for all groups stratified
To access how well the risk prediction by PRISM aligns with observed risk without recalibration. Calibration plots will be created for the whole population and groups stratified by age, sex, race, and geographical location.
Measured: at 1 year
Calibration of PRISM for all groups stratified
To access how well the risk prediction by PRISM aligns with observed risk without recalibration. Calibration plots will be created for the whole population and groups stratified by age, sex, race, and geographical location.
Measured: at 2 years
Calibration of PRISM for all groups stratified
To access how well the risk prediction by PRISM aligns with observed risk without recalibration. Calibration plots will be created for the whole population and groups stratified by age, sex, race, and geographical location.
Measured: at 3 years
PRISM performance metrics of high-risk group for direct screening
To evaluate sensitivity, specificity, PPV, and SIR for patients identified as high-risk by PRISM. Numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Risk threshold determined based on Standardized Incidence Ratio of 5 or greater. The absolute one-year risk thresholds are 0.1834% for PrismNN and 0.2048% risk for PrismLR. SIR 5 or greater was chosen because it is comparable to the current screening inclusion threshold for individuals with an inherited predisposition.
Measured: 6 months from index date
PRISM performance metrics of high-risk group for direct screening
To evaluate sensitivity, specificity, PPV, and SIR for patients identified as high-risk by PRISM. Numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Risk threshold determined based on Standardized Incidence Ratio of 5 or greater. The absolute one-year risk thresholds are 0.1834% for PrismNN and 0.2048% risk for PrismLR. SIR 5 or greater was chosen because it is comparable to the current screening inclusion threshold for individuals with an inherited predisposition.
Measured: at 1 year
PRISM performance metrics of high-risk group for direct screening
To evaluate sensitivity, specificity, PPV, and SIR for patients identified as high-risk by PRISM. Numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Risk threshold determined based on Standardized Incidence Ratio of 5 or greater. The absolute one-year risk thresholds are 0.1834% for PrismNN and 0.2048% risk for PrismLR. SIR 5 or greater was chosen because it is comparable to the current screening inclusion threshold for individuals with an inherited predisposition.
Measured: at 2 years
PRISM performance metrics of high-risk group for direct screening
To evaluate sensitivity, specificity, PPV, and SIR for patients identified as high-risk by PRISM. Numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Risk threshold determined based on Standardized Incidence Ratio of 5 or greater. The absolute one-year risk thresholds are 0.1834% for PrismNN and 0.2048% risk for PrismLR. SIR 5 or greater was chosen because it is comparable to the current screening inclusion threshold for individuals with an inherited predisposition.
Measured: at 3 years
PRISM performance metrics of medium-risk group for biomarker testing
To evaluate sensitivity, specificity, PPV, and SIR for patients identified as medium-risk by PRISM. Numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Risk threshold determined by specificity 85%, with sensitivity around 46%. The absolute one-year risk thresholds are 0.0574% for PrismNN and 0.0564% for PrismLR. Prism operates as a tiered system for identifying individuals in need of screening with this lower risk threshold.
Measured: 6 months from index date
PRISM performance metrics of medium-risk group for biomarker testing
To evaluate sensitivity, specificity, PPV, and SIR for patients identified as medium-risk by PRISM. Numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Risk threshold determined by specificity 85%, with sensitivity around 46%. The absolute one-year risk thresholds are 0.0574% for PrismNN and 0.0564% for PrismLR. Prism operates as a tiered system for identifying individuals in need of screening with this lower risk threshold.
Measured: at 1 year
PRISM performance metrics of medium-risk group for biomarker testing
To evaluate sensitivity, specificity, PPV, and SIR for patients identified as medium-risk by PRISM. Numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Risk threshold determined by specificity 85%, with sensitivity around 46%. The absolute one-year risk thresholds are 0.0574% for PrismNN and 0.0564% for PrismLR. Prism operates as a tiered system for identifying individuals in need of screening with this lower risk threshold.
Measured: at 2 years
PRISM performance metrics of medium-risk group for biomarker testing
To evaluate sensitivity, specificity, PPV, and SIR for patients identified as medium-risk by PRISM. Numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Risk threshold determined by specificity 85%, with sensitivity around 46%. The absolute one-year risk thresholds are 0.0574% for PrismNN and 0.0564% for PrismLR. Prism operates as a tiered system for identifying individuals in need of screening with this lower risk threshold.
Measured: at 3 years
Secondary outcomes (9)
Timing of incident PDAC occurrence
To evaluate how long in advance before PDAC occurrence should be expected for PRISM models to make high-risk predictions. Distribution plots of the date of PDAC incidence for high/medium-risk groups (defined in Outcome 3 and Outcome 4) will be created.
Measured: 6 months from index date
Timing of incident PDAC occurrence
To evaluate how long in advance before PDAC occurrence should be expected for PRISM models to make high-risk predictions. Distribution plots of the date of PDAC incidence for high/medium-risk groups (defined in Outcome 3 and Outcome 4) will be created.
Measured: at 1 year
Timing of incident PDAC occurrence
To evaluate how long in advance before PDAC occurrence should be expected for PRISM models to make high-risk predictions. Distribution plots of the date of PDAC incidence for high/medium-risk groups (defined in Outcome 3 and Outcome 4) will be created.
Measured: at 2 years
Timing of incident PDAC occurrence
To evaluate how long in advance before PDAC occurrence should be expected for PRISM models to make high-risk predictions. Distribution plots of the date of PDAC incidence for high/medium-risk groups (defined in Outcome 3 and Outcome 4) will be created.
Measured: at 3 years
Tumor stage at PDAC diagnosis
stage at diagnosis per tumor registry/pathology report
Measured: 6 months from index date
Tumor stage at PDAC diagnosis
stage at diagnosis per tumor registry/pathology report
Measured: at 1 year
Tumor stage at PDAC diagnosis
stage at diagnosis per tumor registry/pathology report
Measured: at 2 years
Tumor stage at PDAC diagnosis
stage at diagnosis per tumor registry/pathology report
Measured: at 3 years
Long-term timing of incident PDAC occurrence
To characterize the timing of incident PDAC diagnosis among patients prospectively identified as elevated risk by PRISM during extended follow-up. Extended follow-up will evaluate longer-term PDAC occurrence following the observation that PRISM risk elevation may precede PDAC diagnosis by several years.
Measured: Up to 5 years from index date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start21 Apr 2023
- Primary completion8 Jun 2026
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,134,060 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology, TriNetX, LLC
- Responsible party
- Principal investigator, Limor Appelbaum, Beth Israel Deaconess Medical Center
- Investigators
- Limor Appelbaum, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973331
- Sponsor's protocol ID
- 2023Trial
- Status last verified
- Oct 2026
- First submitted
- 17 Jul 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of an EHR-based Model to Predict Pancreatic Cancer Risk Using Multicenter US Data
- ClinicalTrials.gov ID
- NCT05973331
- Acronym / sponsor ID
- 2023Trial
- Conditions
- Pancreatic Adenocarcinoma, Predictive Cancer Model
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 6,134,060 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology, TriNetX, LLC
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 8 Jun 2026 (actual)
- Study completion
- Apr 2028 (estimated)
- First posted
- 2 Aug 2023 (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.
The goal of this prospective observational cohort study is to validate a previously developed pancreatic cancer risk prediction algorith (the PRISM model) using electronic health records from the general population. The main questions it aims to answer are:
- Will a pancreatic cancer risk model, developed on routine EHR data, reliably and accurately predict pancreatic cancer in real-time?
- What is the average time from model deployment and risk prediction, to the date of pancreatic cancer development and what is the stage of pancreatic cancer at diagnosis? The risk model will be deployed on data from individuals eligible for the study. Each individual will be assigned a risk score and tracked over time to assess the model's discriminatory performance and calibration.
Detailed description
To prospectively validate, implement in real-time, and assess performance of an EHR- based PDAC risk-prediction model. To test the hypothesis that our model will reliably predict PDAC in a real-time clinical setting, we will conduct a multi-center prospective cohort study, deploying the PDAC risk model within the TriNetX federated network database, and will take the following steps:
- generate a risk prediction score for each individual under the care of 44 health care organizations (HCOs) in the USA ii) follow all individuals for up to 3 years to assess the primary end-point of PDAC development.
The following metrics will be used to test the discriminative performance and calibration of the EHR-based PDAC risk model in predicting incident PDAC, at the end of the 3-year period:
- AUROC, sensitivity, specificity, PPV/NPV for assessing discrimination
- Calibration: for assessing the accuracy of estimates, based on the estimated to observed number of events
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prospective general opulation cohort | – | Other: Pancreatic Cancer Risk Model (PRISM)Males and females age >= 40 years, without a personal history of PDAC or current PDAC, with at least 2 clinical encounters to the HCO within the year prior to the study start date. |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort will be selected from 44 eligible HCOs comprised of community hospitals, outpatient clinics and academic medical centers from across the US.
Key inclusion criteria (2 listed)
- Male and females age >= 40 years from 44 US HCOs from the TriNetX platform
- at least 2 clinical encounters to the HCO, within the last year, before the study start date
Key exclusion criteria (3 listed)
- Personal history of PDAC or current PDAC
- Age below 40
- Notes on sampling method: no sampling was performed. All eligible individuals are included in this study.
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 |
|---|---|---|
| Pancreatic Cancer Risk Model (PRISM)A neural network model (PrismNN) and a logistic regression model (PrismLR) that use routinely collected EHR data to stratify individuals from the general population into PDAC risk groups | Other | prospective general opulation cohort |
Primary outcome
Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified
Time frame: 6 months from index date
To assess the discriminatory performance of PRISM for prospective identification of high-risk individuals for PDAC development. ROCs and AUROC numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location.
Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified
Time frame: at 1 year
To assess the discriminatory performance of PRISM for prospective identification of high-risk individuals for PDAC development. ROCs and AUROC numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location.
Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified
Time frame: at 2 years
To assess the discriminatory performance of PRISM for prospective identification of high-risk individuals for PDAC development. ROCs and AUROC numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location.
Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified
Time frame: at 3 years
To assess the discriminatory performance of PRISM for prospective identification of high-risk individuals for PDAC development. ROCs and AUROC numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location.
Calibration of PRISM for all groups stratified
Time frame: 6 months from index date
To access how well the risk prediction by PRISM aligns with observed risk without recalibration. Calibration plots will be created for the whole population and groups stratified by age, sex, race, and geographical location.
Calibration of PRISM for all groups stratified
Time frame: at 1 year
To access how well the risk prediction by PRISM aligns with observed risk without recalibration. Calibration plots will be created for the whole population and groups stratified by age, sex, race, and geographical location.
Calibration of PRISM for all groups stratified
Time frame: at 2 years
To access how well the risk prediction by PRISM aligns with observed risk without recalibration. Calibration plots will be created for the whole population and groups stratified by age, sex, race, and geographical location.
Calibration of PRISM for all groups stratified
Time frame: at 3 years
To access how well the risk prediction by PRISM aligns with observed risk without recalibration. Calibration plots will be created for the whole population and groups stratified by age, sex, race, and geographical location.
PRISM performance metrics of high-risk group for direct screening
Time frame: 6 months from index date
To evaluate sensitivity, specificity, PPV, and SIR for patients identified as high-risk by PRISM. Numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Risk threshold determined based on Standardized Incidence Ratio of 5 or greater. The absolute one-year risk thresholds are 0.1834% for PrismNN and 0.2048% risk for PrismLR. SIR 5 or greater was chosen because it is comparable to the current screening inclusion threshold for individuals with an inherited predisposition.
PRISM performance metrics of high-risk group for direct screening
Time frame: at 1 year
To evaluate sensitivity, specificity, PPV, and SIR for patients identified as high-risk by PRISM. Numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Risk threshold determined based on Standardized Incidence Ratio of 5 or greater. The absolute one-year risk thresholds are 0.1834% for PrismNN and 0.2048% risk for PrismLR. SIR 5 or greater was chosen because it is comparable to the current screening inclusion threshold for individuals with an inherited predisposition.
PRISM performance metrics of high-risk group for direct screening
Time frame: at 2 years
To evaluate sensitivity, specificity, PPV, and SIR for patients identified as high-risk by PRISM. Numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Risk threshold determined based on Standardized Incidence Ratio of 5 or greater. The absolute one-year risk thresholds are 0.1834% for PrismNN and 0.2048% risk for PrismLR. SIR 5 or greater was chosen because it is comparable to the current screening inclusion threshold for individuals with an inherited predisposition.
PRISM performance metrics of high-risk group for direct screening
Time frame: at 3 years
To evaluate sensitivity, specificity, PPV, and SIR for patients identified as high-risk by PRISM. Numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Risk threshold determined based on Standardized Incidence Ratio of 5 or greater. The absolute one-year risk thresholds are 0.1834% for PrismNN and 0.2048% risk for PrismLR. SIR 5 or greater was chosen because it is comparable to the current screening inclusion threshold for individuals with an inherited predisposition.
PRISM performance metrics of medium-risk group for biomarker testing
Time frame: 6 months from index date
To evaluate sensitivity, specificity, PPV, and SIR for patients identified as medium-risk by PRISM. Numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Risk threshold determined by specificity 85%, with sensitivity around 46%. The absolute one-year risk thresholds are 0.0574% for PrismNN and 0.0564% for PrismLR. Prism operates as a tiered system for identifying individuals in need of screening with this lower risk threshold.
PRISM performance metrics of medium-risk group for biomarker testing
Time frame: at 1 year
To evaluate sensitivity, specificity, PPV, and SIR for patients identified as medium-risk by PRISM. Numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Risk threshold determined by specificity 85%, with sensitivity around 46%. The absolute one-year risk thresholds are 0.0574% for PrismNN and 0.0564% for PrismLR. Prism operates as a tiered system for identifying individuals in need of screening with this lower risk threshold.
PRISM performance metrics of medium-risk group for biomarker testing
Time frame: at 2 years
To evaluate sensitivity, specificity, PPV, and SIR for patients identified as medium-risk by PRISM. Numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Risk threshold determined by specificity 85%, with sensitivity around 46%. The absolute one-year risk thresholds are 0.0574% for PrismNN and 0.0564% for PrismLR. Prism operates as a tiered system for identifying individuals in need of screening with this lower risk threshold.
PRISM performance metrics of medium-risk group for biomarker testing
Time frame: at 3 years
To evaluate sensitivity, specificity, PPV, and SIR for patients identified as medium-risk by PRISM. Numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Risk threshold determined by specificity 85%, with sensitivity around 46%. The absolute one-year risk thresholds are 0.0574% for PrismNN and 0.0564% for PrismLR. Prism operates as a tiered system for identifying individuals in need of screening with this lower risk threshold.
9 secondary outcomes
Timing of incident PDAC occurrence
Time frame: 6 months from index date
Timing of incident PDAC occurrence
Time frame: at 1 year
Timing of incident PDAC occurrence
Time frame: at 2 years
Timing of incident PDAC occurrence
Time frame: at 3 years
Tumor stage at PDAC diagnosis
Time frame: 6 months from index date
Tumor stage at PDAC diagnosis
Time frame: at 1 year
Tumor stage at PDAC diagnosis
Time frame: at 2 years
Tumor stage at PDAC diagnosis
Time frame: at 3 years
Long-term timing of incident PDAC occurrence
Time frame: Up to 5 years from index date
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 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Limor Appelbaum, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Adenocarcinoma and Predictive Cancer Model, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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 2 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified (time frame: 6 months from index date). The study lists 16 primary outcomes in all. 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 Oct 2026.