An Early Phase 1 interventional study of Screening Blood Tests and Endoscopic Ultrasound in Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma and PDAC, sponsored by Dana-Farber Cancer Institute. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by Dana-Farber Cancer Institute · Early Phase 1, Interventional, and Screening
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.
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants must meet any of the following:
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 familial pancreatic cancer including:
Exclusion Criteria:
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.
Other: Screening Blood Tests · Diagnostic Test: Endoscopic Ultrasound · Combination Product: Magnetic Resonance Imaging · Combination Product: Magnetic Resonance Cholangiopancreatography
Carbohydrate antigen (CA) 19-9, and Hemoglobin A1C (HbA1c) per standard-of-care.
Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
Also known as: EUS
Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
Also known as: MRI
Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
Also known as: MRCP
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.
Time frame: 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.
Time frame: 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.
Time frame: 6-monthly for 3 years with 5-year follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: up to 8 years
Plan to share: 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.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Dana-Farber Cancer Institute