Pancreatic AdenocarcinomaNCT05287347
Panc CA Risk Model & Biomarker Testing In High-Risk Cohort
An observational study of Pancreatic Adenocarcinoma, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to test a double screening strategy for pancreatic cancer, based on a model developed using patient medical records. Investigators would also like to test whether adding specific blood tests, can further help identify people who have a higher risk of pancreatic cancer than the general… Read more about this study
- Who is it for?
- Ages 50 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- Blood Specimen
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 3 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population for part 1 of study: * Inclusion criteria: i) Male and females age >= 50 years; ii) at least one clinical visit to an outpatient clinic of the HCO, within the last year, before the study start date. - Study population for part 2 of study: * i) model-assigned high-risk subjects * ii) Male and females age >= 50 years; * iii) at least one clinical visit to an outpatient clinic of the HCO, within the last year, before the study start date
Who may be able to join
- Study population for part 1 of study:
- -- Inclusion criteria: i) Male and females age >= 50 years; ii) at least one clinical visit to an outpatient clinic of the HCO, within the last year, before the study start date.
- Study population for part 2 of study:
- i) model-assigned high-risk subjects; ii) Male and females age >= 50 years; iii) at least one clinical visit to an outpatient clinic of the HCO, within the last year, before the study start date
Who cannot join
- Personal history of PDAC or current PDAC
- Age below 50.
- model-assigned low or intermediate risk subjects
- Personal history of PDAC or current PDAC
- Age below 50.
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 Multicenter Observational Study for Validation of a Pancreatic Cancer Risk Model and Assessment of the Predictive Value of Blood Biomarkers in a High-risk Cohort
The purpose of this study is to test a double screening strategy for pancreatic cancer, based on a model developed using patient medical records. Investigators would also like to test whether adding specific blood tests, can further help identify people who have a higher risk of pancreatic cancer than the general population, and would benefit from imaging in order to detect cancer early.
Read the detailed description
This research aims to identify people who have a higher risk of pancreatic cancer than the general population, by testing a double-screening strategy for pancreatic cancer. The purpose is to allow early detection of cancer, which potentially leads to cure.
The double-screening will include a computer-based model developed using clinical data from medical records, and three different blood tests for early detection of pancreatic cancer.
Participation in this study involves having medical records followed up for up to three years, and a single donation of blood specimens.
- This is a Combined Retrospective and Prospective Review:
- The first part of the study, involves collection of retrospective data from Electronic Health Record database (for the 3 collaborating HCOs) in order to deploy our EHR model, so that a high-risk group for pancreatic cancer can be identified. All individuals stratified into low, intermediate or high risk groups by the model, will be prospectively, electronically followed to assess outcome.
- The second stage is prospective, and involves requesting biological specimen donations from participants identified as high-risk, for biomarker testing. The prospective "observation period" is up to 3 years (depending on each subject's index date at retrospective recruitment and outcome). Biological specimens will be collected during the prospective "observation period,"
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- Blood Specimen
- Keywords
- Pancreatic Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SpecimenDiagnostic test
Blood samples will be collected from study participants at one time-point in the study, for the following:
- tumor markers CEA and CA 19-9: 2 ml blood will be collected.
- glycomics: 0.5 cc blood will be collected
- ctDNA: 20 cc blood will be collected
| Study group | Role | What they receive |
|---|---|---|
| Prospective | Blood specimens will be obtained for the model-assigned high risk cohort at each collaborating HCO, over two years of recruitment period. Data of each participant will be electronically followed for observation of outcome measures for up to 3 years. Receives: Diagnostic Test: Blood Specimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident PDAC during the 3-year study observation period
The diagnosis of PDAC will be determined by ICD code (ICD10 codes C25.X, excluding C25.4), tumor registry records or pathology reports
Measured: 3 Years
Secondary outcomes (2)
Timing of incident PDAC occurrence
time from index date to diagnosis
Measured: 3 Years
Tumor stage at PDAC diagnosis
stage at diagnosis per tumor registry/pathology report
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Jan 2022
- Primary completion3 Dec 2024
- Study completion3 Dec 2024
Why it stopped: Lack of funding
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.
- 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
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Dana-Farber Cancer Institute
- 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
- NCT05287347
- Sponsor's protocol ID
- 21-490
- Status last verified
- May 2025
- First submitted
- 10 Mar 2022
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Observational Study for Validation of a Pancreatic Cancer Risk Model and Assessment of the Predictive Value of Blood Biomarkers in a High-risk Cohort
- ClinicalTrials.gov ID
- NCT05287347
- Acronym / sponsor ID
- 21-490
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- Pancreatic Adenocarcinoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Dana-Farber Cancer Institute
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 18 Mar 2022 (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 purpose of this study is to test a double screening strategy for pancreatic cancer, based on a model developed using patient medical records. Investigators would also like to test whether adding specific blood tests, can further help identify people who have a higher risk of pancreatic cancer than the general population, and would benefit from imaging in order to detect cancer early.
Detailed description
This research aims to identify people who have a higher risk of pancreatic cancer than the general population, by testing a double-screening strategy for pancreatic cancer. The purpose is to allow early detection of cancer, which potentially leads to cure.
The double-screening will include a computer-based model developed using clinical data from medical records, and three different blood tests for early detection of pancreatic cancer.
Participation in this study involves having medical records followed up for up to three years, and a single donation of blood specimens.
- This is a Combined Retrospective and Prospective Review:
- The first part of the study, involves collection of retrospective data from Electronic Health Record database (for the 3 collaborating HCOs) in order to deploy our EHR model, so that a high-risk group for pancreatic cancer can be identified. All individuals stratified into low, intermediate or high risk groups by the model, will be prospectively, electronically followed to assess outcome.
- The second stage is prospective, and involves requesting biological specimen donations from participants identified as high-risk, for biomarker testing. The prospective "observation period" is up to 3 years (depending on each subject's index date at retrospective recruitment and outcome). Biological specimens will be collected during the prospective "observation period,"
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective | – | Diagnostic Test: Blood SpecimenBlood specimens will be obtained for the model-assigned high risk cohort at each collaborating HCO, over two years of recruitment period. Data of each participant will be electronically followed for observation of outcome measures for up to 3 years. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population for part 1 of study: * Inclusion criteria: i) Male and females age >= 50 years; ii) at least one clinical visit to an outpatient clinic of the HCO, within the last year, before the study start date. - Study population for part 2 of study: * i) model-assigned high-risk subjects * ii) Male and females age >= 50 years; * iii) at least one clinical visit to an outpatient clinic of the HCO, within the last year, before the study start date
Key inclusion criteria (4 listed)
- Study population for part 1 of study:
- -- Inclusion criteria: i) Male and females age >= 50 years; ii) at least one clinical visit to an outpatient clinic of the HCO, within the last year, before the study start date.
- Study population for part 2 of study:
Key exclusion criteria (5 listed)
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 SpecimenBlood samples will be collected from study participants at one time-point in the study, for the following: 1. tumor markers CEA and CA 19-9: 2 ml blood will be collected. 2. glycomics: 0.5 cc blood will be collected 3. ctDNA: 20 cc blood will be collected | Diagnostic test | Prospective |
Primary outcome
Incident PDAC during the 3-year study observation period
Time frame: 3 Years
The diagnosis of PDAC will be determined by ICD code (ICD10 codes C25.X, excluding C25.4), tumor registry records or pathology reports
2 secondary outcomes
Timing of incident PDAC occurrence
Time frame: 3 Years
Tumor stage at PDAC diagnosis
Time frame: 3 Years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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, 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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 25 May 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Incident PDAC during the 3-year study observation period (time frame: 3 Years). 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 25 May 2025; AzTrials last refreshed its copy on 1 Nov 2026.