Pancreatic CancerEarly Phase 1NCT06122896
Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals
A Early Phase 1 study testing Screening Blood Tests, Endoscopic Ultrasound and Magnetic Resonance Imaging in people with Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The purpose of this research is to see if adding blood-based tests and symptom review to standard-of-care pancreatic cancer screening procedures can identify cancer early among individuals with increased risk. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, PDAC
- What is being tested?
- Screening Blood Tests, Endoscopic Ultrasound and Magnetic Resonance Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Nov 2023to 31 Oct 2041
- Phase
- Early Phase 1
- 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
- Participants must meet any of the following:
- Individuals with pathogenic/likely pathogenic germline variants in STK11, and age ≥30 years.
- Individuals with pathogenic/likely pathogenic germline variants in CDKN2A, and age ≥40 years (or 10 years younger than the earliest exocrine pancreatic cancer diagnosis in the family, whichever is earlier).
- Individuals with pathogenic/likely pathogenic germline variants in one of the other pancreatic cancer susceptibility genes (ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, EPCAM, PALB2, TP53), and age ≥50 years (or 10 years younger than the earliest exocrine pancreatic cancer diagnosis in the family, whichever is earlier) AND
- Exocrine pancreatic cancer in ≥1 first- or second-degree relative from the same side of (or presumed to be from the same side of) the family as the identified pathogenic/likely pathogenic germline variant.
- Individuals with pathogenic/likely pathogenic variants in PRSS1 AND a clinical phenotype consistent with hereditary pancreatitis, and age ≥40 years (or 20 years after onset of pancreatitis, whichever is earlier).
Show all 11Show fewer
- Individuals with familial pancreatic cancer including:
- Family history of exocrine pancreatic cancer in ≥2 first-degree relatives from the same side of the family, even in the absence of a known pathogenic/likely pathogenic germline variant, OR
- Family history of exocrine pancreatic cancer in 1 affected first-degree relative and 1 second-degree relative, even in the absence of a known pathogenic/likely pathogenic germline variant, OR
- Family history of exocrine pancreatic cancer in ≥3 first- and/or second-degree relatives from the same side of the family, even in the absence of a known pathogenic/likely pathogenic germline variant.
- Individuals who are undergoing clinically recommended pancreatic cancer surveillance.
Who cannot join
- Individuals with active or prior pancreatic ductal adenocarcinoma diagnosis.
- Individuals with any active metastatic cancer.
- Individuals who are unable to give informed consent.
- Individuals who are under the age of 18 (infants, children, teenagers).
- Individuals unable to tolerate Magnetic Resonance Imaging/Magnetic Resonance Cholangiopancreatography and Endoscopic Ultrasound.
- Pregnant women are unlikely to be undergoing screening procedures and will not be considered eligible but can consent to the study at a later date.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Matthew Yurgelun, MD, 617-582-8673, matthew_yurgelun@dfci.harvard.edu
Matthew Yurgelun, MD
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Matthew Yurgelun, MD, 617-582-8673, matthew_yurgelun@dfci.harvard.edu
Matthew B Yurgelun, MD
About this study
The purpose of this research is to see if adding blood-based tests and symptom review to standard-of-care pancreatic cancer screening procedures can identify cancer early among individuals with increased risk.
Read the detailed description
In this research study, investigators will combine blood-based tests and review of symptoms with standard-of-care pancreatic cancer screening procedures to see if pancreatic cancer can be detected early among individuals with increased risk. Pancreatic cancer screening procedures include Endoscopic Ultrasound (EUS), Magnetic Resonance Imaging (MRI), or Magnetic Resonance Cholangiopancreatography (MRCP).
The research study procedures include screening for eligibility, questionnaires, clinic visits, endoscopic ultrasound (EUS) or Magnetic Resonance (MRI)/Magnetic Resonance Cholangiopancreatography (MRCP), and collection of blood, stool, and saliva samples.
Participation in this research study will be a minimum of 30 months and up to 20 years via review of medical records and the annual collection of blood and stool samples.
It is expected that about 5,000 people will take part in this research study.
This study is supported by the Hale Family Research Center at Dana-Farber Cancer Institute.
- Conditions
- Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, Pancreatic Neoplasm
- Being tested
- Screening Blood Tests, Endoscopic Ultrasound, Magnetic Resonance Imaging, Magnetic Resonance Cholangiopancreatography
- Keywords
- Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, Pancreatic Neoplasm
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening Blood TestsOther
Carbohydrate antigen (CA) 19-9, and Hemoglobin A1C (HbA1c) per standard-of-care.
Endoscopic UltrasoundDiagnostic test
Also called EUS
Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
Magnetic Resonance ImagingCombination product
Also called MRI
Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
Magnetic Resonance CholangiopancreatographyCombination product
Also called MRCP
Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic Cancer High-Risk Participants | Experimental | Study procedures will be conducted as follows:
* Baseline visit with questionnaires, blood tests, and pancreas screening procedure (EUS or MRI/MRCP).
* Pancreas screening procedures (Endoscopic ultrasound (EUS), or Magnetic Resonance (MRI)/Magnetic Resonance Cholangiopancreatography (MRCP), and collection of blood, stool, and saliva samples) every 12 months.
* Blood tests and questionnaires every 6 months.
* Follow up visits. Receives: Other: Screening Blood Tests; Diagnostic Test: Endoscopic Ultrasound; Combination Product: Magnetic Resonance Imaging; Combination Product: Magnetic Resonance Cholangiopancreatography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Incident Pancreatic Cancers or High-Grade Pancreatic Neoplasms
Subjects will be counted in this metric if they have pathological tissue confirmation of a pancreatic cancer or high-grade dysplasia during each observation period.
Measured: 6-monthly for 3 years with 5-year follow-up
Number of Imaging-Positive Pancreatic Cancers or High-Grade Neoplasms
Subjects will be considered imaging-positive if they have a biopsy-confirmed pancreatic ductal adenocarcinoma or high-grade dysplasia that was initially detected on standard-of-care screening MRI or EUS during each observation period.
Measured: 6-monthly for 3 years with 5-year follow-up
Number of Imaging-Negative, Assay-Positive Pancreatic Cancers or High-Grade Neoplasms
Subjects will be considered imaging-negative and assay-positive if: 1) the subject has a study visit that yields any newly positive CA19-9 (>35U/mL or >=20% increase) or diabetes (FBG >100mg/dL for first time or HgbA1c increased by 0.5) assay result or ENDPAC score >=3 with negative MRI and/or EUS at that visit or within six months prior to that visit; and 2) has a biopsy-confirmed pancreatic ductal adenocarcinoma or high-grade dysplasia within two years after that visit.
Measured: 6-monthly for 3 years with 5-year follow-up
Secondary outcomes (8)
Positive Predictive Value of Blood Assays
Positive predictive value of blood assays, defined as newly positive CA19-9 (>35U/mL or >=20% increase) or diabetes (FBG >100mg/dL for first time or HgbA1c increased by 0.5) assay result or ENDPAC score >=3, with a positive biopsy for PDAC or High-Grade Dysplasia within six months divided by the total number with a positive blood assay.
Measured: 6-monthly for 3 years
Negative Predictive Value of Blood Assays
Negative predictive value of blood assays, defined as CA19-9 (<=35U/mL or <20% increase) or diabetes (FBG <100mg/dL for first time or HgbA1c increased by less than 0.5) assay result or ENDPAC score <3, without a positive biopsy for PDAC or High-Grade Dysplasia within six months divided by the total number with a negative blood assay.
Measured: 6-monthly for 3 years
Proportion of Screen-Detected, Resected Pancreatic Lesions
Number of screen-detected pancreatic lesions that are resected compared to the total number of screen-detected pancreatic lesions.
Measured: 6-monthly for 3 years
Proportion of Non-Worrisome Pancreatic Lesions
Number of pancreatic lesions that are biopsied without cancer or high-grade dysplasia divided by number of pancreatic lesions that are biopsied.
Measured: 6-monthly for 3 years
Incremental Yield of Blood-Based Assays over Standard-of-Care Screening
Number of imaging-negative, assay-positive cases showing cancer or high-grade dysplasia divided by the total number of imaging-negative cases with cancer or high-grade dysplasia.
Measured: 6-monthly for 3 years
Number of False-Positive Assay Results
Number of positive assay results, defined as newly positive CA19-9 (>35U/mL or >=20% increase) or diabetes (FBG >100mg/dL for first time or HgbA1c increased by 0.5) assay result or ENDPAC score >=3, without a clinical diagnosis of pancreatic cancer within one year.
Measured: 6-monthly for 3 years
Number of Non-PDAC Cancer Diagnoses
Number of non-PDAC cancer detected through blood-based assays, EUS and/or MRI during the active screening period.
Measured: 6-monthly for 3 years
Clinical Predictors of Neoplastic Development
Frequencies of clinical predictors of neoplastic development as indicated by responses to the study surveys.
Measured: up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start21 Nov 2023
- Primary completion31 Oct 2040 (estimated)
- Study completion31 Oct 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew B. Yurgelun, MD, Dana-Farber Cancer Institute
- Investigators
- Matthew Yurgelun, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122896
- Sponsor's protocol ID
- 23-147
- Status last verified
- May 2026
- First submitted
- 3 Nov 2023
- Last updated
- 29 May 2026
- 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: Matthew Yurgelun, Matthew\_Yurgelun@dfci.harvard.edu. 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 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals
- ClinicalTrials.gov ID
- NCT06122896
- Acronym / sponsor ID
- 23-147
- Conditions
- Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, Pancreatic Neoplasm
- Keywords
- Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, Pancreatic Neoplasm
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 31 Oct 2040 (estimated)
- Study completion
- 31 Oct 2041 (estimated)
- First posted
- 8 Nov 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 purpose of this research is to see if adding blood-based tests and symptom review to standard-of-care pancreatic cancer screening procedures can identify cancer early among individuals with increased risk.
Detailed description
In this research study, investigators will combine blood-based tests and review of symptoms with standard-of-care pancreatic cancer screening procedures to see if pancreatic cancer can be detected early among individuals with increased risk. Pancreatic cancer screening procedures include Endoscopic Ultrasound (EUS), Magnetic Resonance Imaging (MRI), or Magnetic Resonance Cholangiopancreatography (MRCP).
The research study procedures include screening for eligibility, questionnaires, clinic visits, endoscopic ultrasound (EUS) or Magnetic Resonance (MRI)/Magnetic Resonance Cholangiopancreatography (MRCP), and collection of blood, stool, and saliva samples.
Participation in this research study will be a minimum of 30 months and up to 20 years via review of medical records and the annual collection of blood and stool samples.
It is expected that about 5,000 people will take part in this research study.
This study is supported by the Hale Family Research Center at Dana-Farber Cancer Institute.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatic Cancer High-Risk Participants | Experimental | Other: Screening Blood Tests, Diagnostic Test: Endoscopic Ultrasound, Combination Product: Magnetic Resonance Imaging, Combination Product: Magnetic Resonance CholangiopancreatographyStudy procedures will be conducted as follows: * Baseline visit with questionnaires, blood tests, and pancreas screening procedure (EUS or MRI/MRCP). * Pancreas screening procedures (Endoscopic ultrasound (EUS), or Magnetic Resonance (MRI)/Magnetic Resonance Cholangiopancreatography (MRCP), and collection of blood, stool, and saliva samples) every 12 months. * Blood tests and questionnaires every 6 months. * Follow up visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Individuals with pathogenic/likely pathogenic germline variants in STK11, and age ≥30 years.
- Individuals with pathogenic/likely pathogenic germline variants in CDKN2A, and age ≥40 years (or 10 years younger than the earliest exocrine pancreatic cancer diagnosis in the family, whichever is earlier).
- Individuals with pathogenic/likely pathogenic germline variants in one of the other pancreatic cancer susceptibility genes (ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, EPCAM, PALB2, TP53), and age ≥50 years (or 10 years younger than the earliest exocrine pancreatic cancer diagnosis in the family, whichever is earlier) AND
- Individuals with pathogenic/likely pathogenic variants in PRSS1 AND a clinical phenotype consistent with hereditary pancreatitis, and age ≥40 years (or 20 years after onset of pancreatitis, whichever is earlier).
- Individuals with familial pancreatic cancer including:
Key exclusion criteria (6 listed)
- Individuals with active or prior pancreatic ductal adenocarcinoma diagnosis.
- Individuals with any active metastatic cancer.
- Individuals who are unable to give informed consent.
- Individuals who are under the age of 18 (infants, children, teenagers).
- Individuals unable to tolerate Magnetic Resonance Imaging/Magnetic Resonance Cholangiopancreatography and Endoscopic Ultrasound.
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 |
|---|---|---|
| Screening Blood TestsCarbohydrate antigen (CA) 19-9, and Hemoglobin A1C (HbA1c) per standard-of-care. | Other | Pancreatic Cancer High-Risk Participants |
| Endoscopic UltrasoundAlso: EUSAnnually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines. | Diagnostic test | Pancreatic Cancer High-Risk Participants |
| Magnetic Resonance ImagingAlso: MRIAnnually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines. | Combination product | Pancreatic Cancer High-Risk Participants |
| Magnetic Resonance CholangiopancreatographyAlso: MRCPAnnually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines. | Combination product | Pancreatic Cancer High-Risk Participants |
Primary outcome
Number of Incident Pancreatic Cancers or High-Grade Pancreatic Neoplasms
Time frame: 6-monthly for 3 years with 5-year follow-up
Subjects will be counted in this metric if they have pathological tissue confirmation of a pancreatic cancer or high-grade dysplasia during each observation period.
Number of Imaging-Positive Pancreatic Cancers or High-Grade Neoplasms
Time frame: 6-monthly for 3 years with 5-year follow-up
Subjects will be considered imaging-positive if they have a biopsy-confirmed pancreatic ductal adenocarcinoma or high-grade dysplasia that was initially detected on standard-of-care screening MRI or EUS during each observation period.
Number of Imaging-Negative, Assay-Positive Pancreatic Cancers or High-Grade Neoplasms
Time frame: 6-monthly for 3 years with 5-year follow-up
Subjects will be considered imaging-negative and assay-positive if: 1) the subject has a study visit that yields any newly positive CA19-9 (>35U/mL or >=20% increase) or diabetes (FBG >100mg/dL for first time or HgbA1c increased by 0.5) assay result or ENDPAC score >=3 with negative MRI and/or EUS at that visit or within six months prior to that visit; and 2) has a biopsy-confirmed pancreatic ductal adenocarcinoma or high-grade dysplasia within two years after that visit.
8 secondary outcomes
Positive Predictive Value of Blood Assays
Time frame: 6-monthly for 3 years
Negative Predictive Value of Blood Assays
Time frame: 6-monthly for 3 years
Proportion of Screen-Detected, Resected Pancreatic Lesions
Time frame: 6-monthly for 3 years
Proportion of Non-Worrisome Pancreatic Lesions
Time frame: 6-monthly for 3 years
Incremental Yield of Blood-Based Assays over Standard-of-Care Screening
Time frame: 6-monthly for 3 years
Number of False-Positive Assay Results
Time frame: 6-monthly for 3 years
Number of Non-PDAC Cancer Diagnoses
Time frame: 6-monthly for 3 years
Clinical Predictors of Neoplastic Development
Time frame: up to 8 years
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 29 May 2026.
- 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: Matthew Yurgelun, Matthew_Yurgelun@dfci.harvard.edu. 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.
Matthew Yurgelun, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Screening Blood Tests, Endoscopic Ultrasound and Magnetic Resonance Imaging in people with Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma, run by Dana-Farber Cancer Institute at 2 sites 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 11 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Matthew Yurgelun, MD (617-582-8673, matthew_yurgelun@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Incident Pancreatic Cancers or High-Grade Pancreatic Neoplasms (time frame: 6-monthly for 3 years with 5-year follow-up). The study lists 3 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 29 May 2026.