Pancreatic Cancer, AdultPancreasScanNCT05006131
Pancreatic Cancer Screening for At-risk Individuals
An observational study of Pancreatic Cancer, Adult, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The investigators' goal is to conduct a prospective multicenter study to evaluate the yield and outcomes of screening of pancreas cancer in individuals who are at-risk for pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pancreatic Cancer, Adult
- What is being tested?
- Screening for pancreatic cancer
- How many people
- 1,395 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2020to 31 Dec 2032
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient who meets the eligibility criteria exposed above based on CAPS3 or updated national pancreatic screening guidelines criteria at BIDMC and collaboration centers part of the study in the time frame of 2020 to 2027 (which is the end of enrollment)
Who may be able to join
- Inclusion criteria 1-3 are indications for pancreatic cancer screening as defined by the CAPS3 guidelines or updated national pancreatic cancer screening guidelines. Patients who do not meet these guidelines but are undergoing pancreatic cancer screening at the discretion of their treating physician at participating study centers will also be included in the study. Based upon the indication for screening, patients will be categorized as either meeting CAPS3 screening criteria, or not meeting CAPS3 screening criteria.
- Familial Pancreatic cancer kindred. This is defined as family history of pancreas cancer that meet the criteria listed below.
- If at least two affected relatives who are First degree relatives (FDR) to each other, of whom at least one is an FDR to the individual considered for surveillance
- If at least three affected relatives on the same side of the family, of whom at least one is an FDR to the individual considered for surveillance
- If at least two affected relatives on the same side of the family, of whom at least one is an FDR to the individual considered for surveillance Screening is usually initialed at age 50 years or 10 years younger than the youngest family member with pancreatic cancer
- Patients with genetic susceptibility to pancreas cancer
Show all 16Show fewer
- Patients with Peutz-Jeghers syndrome diagnosed with using clinical criteria or with a deleterious mutation in liver kinase B1/Serine/threonine kinase 11 (LKB1/STK11). Screening is usually initiated at age 40 years or later.
- Patients with Familial Atypical Multiple Mole Melanoma Syndrome (FAMMM syndrome), diagnosed using clinical criteria or CDKN2A p16 mutation.
- Screening is usually initiated at age 45 years or 10 years younger than the youngest family member with pancreatic cancer.
- Hereditary Breast and Ovarian Cancer syndrome: diagnosed using clinical criteria or deleterious Breast Cancer gene 1 (BRCA1), Breast Cancer gene 2 (BRCA2), Partner and Localizer of BRCA2 (PALB2). The usual indication for screening is:
- BRCA1 mutation and at least one affected first-degree relative with pancreatic cancer
- BRCA 2 mutation and at least one affected first-degree relative, or at least two relatives of any degree with pancreatic cancer
- PALB2 mutation and at least one affected first-degree relative with pancreatic cancer Screening is usually initiated at age 45 or 10 years younger than the youngest family member with pancreatic cancer; or per updated national screening guidelines
- Lynch syndrome or Ataxia Telangiectasia Mutated (ATM) mutations with at least one affected first-degree relative (FDR). Lynch syndrome could be diagnosed either by using clinical criteria or Mutator L homolog 1 (MLH1), Mutator S homolog 2 (MSH2), Mutator S homolog 6 (MSH6), Postmeiotic Segregation Increased, S. Cerevisiae, 2 (PMS2) or EPCAM mutation.
- Screening to be initiated at age 45 or 10 years younger than the youngest family member with pancreatic cancer.
- Patients with hereditary pancreatitis diagnosed using clinical criteria or deleterious Serine Protease 1 (PRSS1) mutation. Screening is usually initiated at age 40 years or 10 years younger than the youngest family member with pancreatic cancer 3. New-onset diabetes, age > 50 years with weight loss. 4. Patients who do not meet these CAPS screening criteria but are determined by the site principal investigator to be high-risk for pancreatic cancer based upon family history or other risk factors, and are undergoing pancreatic cancer screening will also be included in the study. Indication for pancreatic cancer screening and age at which screening was initiated will be recorded.
Who cannot join
- Patients presenting with symptoms suggestive of pancreatic cancer who are undergoing diagnostic EUS or MRCP e.g. acute recurrent pancreatitis, abnormal imaging
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Roya Dastjerdi, MPH, 617 667 4046, rdastjer@bidmc.harvard.edu
Mandeep Sawhney, MD,MS,FASGE
About this study
Official title: Pancreatic Cancer Screening for At-risk Individuals (The Pancreas Scan Study)
The investigators' goal is to conduct a prospective multicenter study to evaluate the yield and outcomes of screening of pancreas cancer in individuals who are at-risk for pancreatic cancer. We plan to use International Cancer of the Pancreas Screening (CAPS3) Consortium recommendations to standardize study population, screening methodology, and study outcomes.
Read the detailed description
Methods The investigators' goal is to conduct a prospective multicenter study to evaluate the yield and outcomes of pancreas cancer screening in high-risk individuals. High-risk patients who are undergoing pancreatic cancer screening in accordance with national guidelines at participating study centers will be eligible for the study. Information regarding patient characteristics, findings at screening examination, and patient outcomes will be collected.
Primary Outcome (Primary Aim):
To identify the proportion of patients who meet International Cancer of the Pancreas Screening Consortium screening criteria 3rd update (CAPS Jan 2020), or more updated national guidelines, who are found at the screening to have high-risk pancreatic lesions amenable to treatment (definition of "high-risk lesions amenable to treatment" is provided under the section on study outcomes).
Secondary outcomes (Secondary Aims) will include (details are provided under the section on study outcomes):
- Proportion of patients diagnosed with any stage pancreatic cancer
- proportion of patients undergoing pancreatic surgery
- Cancer-related outcome, defined as a cancer-related death
- proportion of patients experience harms, defined as any complications/adverse event due to screen related procedures
- Comparison of cancer outcome, defined cancer-related death, in screen-detected cancer with cancer outcomes reported by the SEERs population-based registry. Study overview Study type: a prospective observational cohort. High-risk patients who meet study inclusion criteria at study centers will be identified.
Screening and patient follow-up will be performed at individual study centers per standard clinical practice. Patient characteristics, screening performed and screening results, clinical outcome data will be collected by individual study centers. This data will be stored and analyzed at central study REDCap located at Beth Israel Deaconess Medical Center (BIDMC)
- Conditions
- Pancreatic Cancer, Adult
- Being tested
- Screening for pancreatic cancer
- Keywords
- Pancreatic cancer screening, Early detection of pancreatic cancer, Genetic susceptibility to pancreatic cancer, BRCA 1, BRCA 2, familial pancreatic cancer, Endoscopic Ultrasound, MRI
- Medical subject headings
- Pancreatic cancer, adult, Pancreatic carcinoma, familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening for pancreatic cancerOther
Screening for pancreatic cancer using EUS or MRI
| Study group | Role | What they receive |
|---|---|---|
| Patients who are at high-risk for pancreatic cancer | Patients that meet the eligibility criteria based on CAPS3 or updated national pancreatic cancer screening guidelines Receives: Other: Screening for pancreatic cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of screening patients found to have high-risk pancreatic lesions amenable to treatment
Proportion of patients who meet CAPS 3 or updated national screening guidelines criteria who are found at screening to have high-risk pancreatic lesions amenable to treatment.
These are defined as the following:
- Lesions with high-grade dysplasia (HGD)
- High-grade pancreatic intraepithelial neoplasia (PanIN)
- Resectable or borderline resectable pancreatic cancer. Pancreatic cancers that were staged T1-3, N0-2, and M0 designated as resectable or borderline resectable. Cancers that were staged as T4 or M1 were considered locally advanced or metastatic and therefore designated as unresectable
- Main duct intra-ductal papillary mucinous neoplasm (IPMN).This will be defined per Fukuoko guidelines as dilation of main pancreatic duct ≥ 5 mm, after duct dilation due to other causes have been excluded.
- Branch-duct IPMN with "worrisome features".
- Neuroendocrine tumor ≥ 2 cm.
Measured: From year 1 to year 12 (until the end of at least 5 years follow up in 2032), according to the standard of care designated by GI team.
Secondary outcomes (6)
Proportion of screening patients found to have high-risk pancreatic lesions
Proportion of patients who meet CAPS screening eligibility criteria, who are found at screening to have high-risk pancreatic lesions amenable to treatment
Measured: From year 1 screening to year 12 (end of at least 5 years follow up in 2032) screening (annually)
Proportion of screening patients found to have low or moderate-risk pancreatic lesions by screening
Proportion of patients undergoing pancreatic cancer screening who are found to have low or moderate-risk pancreatic lesions. Low or moderate-risk pancreatic lesions pancreatic lesions are defined as:
- Branch-duct IPMN without HGD
- Neuroendocrine tumor < 2 cm
- dilation of main pancreatic duct < 8 mm
- Chronic pancreatitis-like change
Measured: From year 1 to year 12 (end of at least 5 years follow up in 2032) according to the standard of care designated by GI team.
Proportion of patients undergoing screening who undergo pancreatic surgery
Proportion of patients who undergo pancreatic surgery as a result of screening test results following the Fukuoka revised guidelines for the management for high-risk lesions or surgical treatment designated by interdisciplinary medical team
Measured: From year 1 to year 12, which is the end of at least 5 years follow up in 2032.(throughout the duration of the study)
Proportion of "low yield" pancreatic surgeries performed in screening patients
Proportion of patients who undergo "low-yield pancreatic surgery" as a result of screening test results. Low yield pancreatic surgery is defined surgery where surgical pathology does not yield high-risk pancreatic lesions. See primary outcome for definition of high-risk pancreatic lesions.
Measured: From year 1 to year 12, which is the end of at least 5 years follow up in 2032.(throughout the duration of the study)
Proportion of screening patients who undergo non-pancreatic surgery
Proportion of patients who undergo non- pancreatic surgery as a result of screening test results.
Measured: From year 1 to year 12 (the end of at least 5 years follow up in 2032), according to the standard of care designated by GI team
Proportion of screening patients who experience complications/adverse events of screen-related procedures
Proportion of patients who experienced any complications or adverse events due to screen-related procedures as Endoscopic Ultrasound (EUS), Magnetic resonance cholangiopancreatography (MRCP) or others that have been designated by attending in the GI department. Complications and adverse events will be aggregated to be reported as one value (complications/adverse events). Complications, defined as adverse events that emphasize direct causality between medical care and the adverse outcome or event. Adverse event, defined as an event that may or may not be preventable or result from a medical error
Measured: From year 1 to year 12 (the end of at least 5 years follow up in 2032), according to standard of care designated by GI team
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start10 Jul 2020
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Cancer, AdultStudies 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
- 1,395 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine, Zucker School of Medicine at Hofstra/Northwell, Rush University Medical Center, Wake Forest University, University of Arkansas
- Responsible party
- Principal investigator, Mandeep Sawhney, Beth Israel Deaconess Medical Center
- Investigators
- Mandeep Sawhney, MD,MS,FASGE, Principal investigator, BIDMC-Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006131
- Sponsor's protocol ID
- 2020P000872
- Acronym
- PancreasScan
- Status last verified
- Apr 2026
- First submitted
- 18 Jul 2021
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Borgida, A., Holter, S., Thomas, C., Jhaveri, K., Haider, M. A., & Gallinger, S. Screening individuals at increased risk for pancreatic cancer using biannual contrast MRI. Familial Cancer, 2017, 16 (1 Supplement 1), S108
Canto MI, Almario JA, Schulick RD, Yeo CJ, Klein A, Blackford A, Shin EJ, Sanyal A, Yenokyan G, Lennon AM, Kamel IR, Fishman EK, Wolfgang C, Weiss M, Hruban RH, Goggins M. Risk of Neoplastic Progression in Individuals at High Risk for Pancreatic Cancer Undergoing Long-term Surveillance. Gastroenterology. 2018 Sep;155(3):740-751.e2. doi: 10.1053/j.gastro.2018.05.035. Epub 2018 May 24.
PubMed 29803839Corral JE, Mareth KF, Riegert-Johnson DL, Das A, Wallace MB. Diagnostic Yield From Screening Asymptomatic Individuals at High Risk for Pancreatic Cancer: A Meta-analysis of Cohort Studies. Clin Gastroenterol Hepatol. 2019 Jan;17(1):41-53. doi: 10.1016/j.cgh.2018.04.065. Epub 2018 Jun 30.
PubMed 29775792Gangi A, Malafa M, Klapman J. Endoscopic Ultrasound-Based Pancreatic Cancer Screening of High-Risk Individuals: A Prospective Observational Trial. Pancreas. 2018 May/Jun;47(5):586-591. doi: 10.1097/MPA.0000000000001038.
PubMed 29683970Goggins M, Overbeek KA, Brand R, Syngal S, Del Chiaro M, Bartsch DK, Bassi C, Carrato A, Farrell J, Fishman EK, Fockens P, Gress TM, van Hooft JE, Hruban RH, Kastrinos F, Klein A, Lennon AM, Lucas A, Park W, Rustgi A, Simeone D, Stoffel E, Vasen HFA, Cahen DL, Canto MI, Bruno M; International Cancer of the Pancreas Screening (CAPS) consortium. Management of patients with increased risk for familial pancreatic cancer: updated recommendations from the International Cancer of the Pancreas Screening (CAPS) Consortium. Gut. 2020 Jan;69(1):7-17. doi: 10.1136/gutjnl-2019-319352. Epub 2019 Oct 31.
PubMed 31672839Kogekar N, Diaz KE, Weinberg AD, Lucas AL. Surveillance of high-risk individuals for pancreatic cancer with EUS and MRI: A meta-analysis. Pancreatology. 2020 Dec;20(8):1739-1746. doi: 10.1016/j.pan.2020.10.025. Epub 2020 Oct 9.
PubMed 33077384Kwon, R., Dust, H., McCarthy, S., Hosmer, A., Carulli, A., Scheiman, J., . . . Stoffel, E Outcomes of pancreatic cancer surveillance in high risk individuals. American Journal of Gastroenterology, 2019, 114 (Supplement), S19.
Lachter J, Rosenberg C, Hananiya T, Khamaysi I, Klein A, Yassin K, Half E. Screening to Detect Precursor Lesions of Pancreatic Adenocarcinoma in High-risk Individuals: A Single-center Experience. Rambam Maimonides Med J. 2018 Oct 4;9(4):e0029. doi: 10.5041/RMMJ.10353.
PubMed 30309438Rahib L, Smith BD, Aizenberg R, Rosenzweig AB, Fleshman JM, Matrisian LM. Projecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the United States. Cancer Res. 2014 Jun 1;74(11):2913-21. doi: 10.1158/0008-5472.CAN-14-0155.
PubMed 24840647Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
PubMed 31912902Tanaka M, Fernandez-Del Castillo C, Kamisawa T, Jang JY, Levy P, Ohtsuka T, Salvia R, Shimizu Y, Tada M, Wolfgang CL. Revisions of international consensus Fukuoka guidelines for the management of IPMN of the pancreas. Pancreatology. 2017 Sep-Oct;17(5):738-753. doi: 10.1016/j.pan.2017.07.007. Epub 2017 Jul 13.
PubMed 28735806van Roessel S, Kasumova GG, Verheij J, Najarian RM, Maggino L, de Pastena M, Malleo G, Marchegiani G, Salvia R, Ng SC, de Geus SW, Lof S, Giovinazzo F, van Dam JL, Kent TS, Busch OR, van Eijck CH, Koerkamp BG, Abu Hilal M, Bassi C, Tseng JF, Besselink MG. International Validation of the Eighth Edition of the American Joint Committee on Cancer (AJCC) TNM Staging System in Patients With Resected Pancreatic Cancer. JAMA Surg. 2018 Dec 1;153(12):e183617. doi: 10.1001/jamasurg.2018.3617. Epub 2018 Dec 19.
PubMed 30285076Shah I, Silva-Santisteban A, Germansky KA, Trindade A, Raphael KL, Kushnir V, Pawa R, Mishra G, Anastasiou J, Inamdar S, Tharian B, Bilal M, Sawhney MS. Pancreatic Cancer Screening for At-Risk Individuals (Pancreas Scan Study): Yield, Harms, and Outcomes From a Prospective Multicenter Study. Am J Gastroenterol. 2023 Sep 1;118(9):1664-1670. doi: 10.14309/ajg.0000000000002314. Epub 2023 May 4.
PubMed 37141538
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Cancer Screening for At-risk Individuals (The Pancreas Scan Study)
- ClinicalTrials.gov ID
- NCT05006131
- Acronym / sponsor ID
- PancreasScan / 2020P000872
- Conditions
- Pancreatic Cancer, Adult
- Keywords
- Pancreatic cancer screening, Early detection of pancreatic cancer, Genetic susceptibility to pancreatic cancer, BRCA 1, BRCA 2, familial pancreatic cancer, Endoscopic Ultrasound, MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,395 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Washington University School of Medicine, Zucker School of Medicine at Hofstra/Northwell, Rush University Medical Center, Wake Forest University, University of Arkansas
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 16 Aug 2021 (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 investigators' goal is to conduct a prospective multicenter study to evaluate the yield and outcomes of screening of pancreas cancer in individuals who are at-risk for pancreatic cancer. We plan to use International Cancer of the Pancreas Screening (CAPS3) Consortium recommendations to standardize study population, screening methodology, and study outcomes.
Detailed description
Methods The investigators' goal is to conduct a prospective multicenter study to evaluate the yield and outcomes of pancreas cancer screening in high-risk individuals. High-risk patients who are undergoing pancreatic cancer screening in accordance with national guidelines at participating study centers will be eligible for the study. Information regarding patient characteristics, findings at screening examination, and patient outcomes will be collected.
Primary Outcome (Primary Aim):
To identify the proportion of patients who meet International Cancer of the Pancreas Screening Consortium screening criteria 3rd update (CAPS Jan 2020), or more updated national guidelines, who are found at the screening to have high-risk pancreatic lesions amenable to treatment (definition of "high-risk lesions amenable to treatment" is provided under the section on study outcomes).
Secondary outcomes (Secondary Aims) will include (details are provided under the section on study outcomes):
- Proportion of patients diagnosed with any stage pancreatic cancer
- proportion of patients undergoing pancreatic surgery
- Cancer-related outcome, defined as a cancer-related death
- proportion of patients experience harms, defined as any complications/adverse event due to screen related procedures
- Comparison of cancer outcome, defined cancer-related death, in screen-detected cancer with cancer outcomes reported by the SEERs population-based registry. Study overview Study type: a prospective observational cohort. High-risk patients who meet study inclusion criteria at study centers will be identified.
Screening and patient follow-up will be performed at individual study centers per standard clinical practice. Patient characteristics, screening performed and screening results, clinical outcome data will be collected by individual study centers. This data will be stored and analyzed at central study REDCap located at Beth Israel Deaconess Medical Center (BIDMC)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who are at high-risk for pancreatic cancer | – | Other: Screening for pancreatic cancerPatients that meet the eligibility criteria based on CAPS3 or updated national pancreatic cancer screening guidelines |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient who meets the eligibility criteria exposed above based on CAPS3 or updated national pancreatic screening guidelines criteria at BIDMC and collaboration centers part of the study in the time frame of 2020 to 2027 (which is the end of enrollment)
Key inclusion criteria (16 listed)
- Inclusion criteria 1-3 are indications for pancreatic cancer screening as defined by the CAPS3 guidelines or updated national pancreatic cancer screening guidelines. Patients who do not meet these guidelines but are undergoing pancreatic cancer screening at the discretion of their treating physician at participating study centers will also be included in the study. Based upon the indication for screening, patients will be categorized as either meeting CAPS3 screening criteria, or not meeting CAPS3 screening criteria.
- Screening is usually initiated at age 45 years or 10 years younger than the youngest family member with pancreatic cancer.
- Hereditary Breast and Ovarian Cancer syndrome: diagnosed using clinical criteria or deleterious Breast Cancer gene 1 (BRCA1), Breast Cancer gene 2 (BRCA2), Partner and Localizer of BRCA2 (PALB2). The usual indication for screening is:
- Lynch syndrome or Ataxia Telangiectasia Mutated (ATM) mutations with at least one affected first-degree relative (FDR). Lynch syndrome could be diagnosed either by using clinical criteria or Mutator L homolog 1 (MLH1), Mutator S homolog 2 (MSH2), Mutator S homolog 6 (MSH6), Postmeiotic Segregation Increased, S. Cerevisiae, 2 (PMS2) or EPCAM mutation.
- Screening to be initiated at age 45 or 10 years younger than the youngest family member with pancreatic cancer.
Key exclusion criteria (1 listed)
- Patients presenting with symptoms suggestive of pancreatic cancer who are undergoing diagnostic EUS or MRCP e.g. acute recurrent pancreatitis, abnormal imaging
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 for pancreatic cancerScreening for pancreatic cancer using EUS or MRI | Other | Patients who are at high-risk for pancreatic cancer |
Primary outcome
Proportion of screening patients found to have high-risk pancreatic lesions amenable to treatment
Time frame: From year 1 to year 12 (until the end of at least 5 years follow up in 2032), according to the standard of care designated by GI team.
Proportion of patients who meet CAPS 3 or updated national screening guidelines criteria who are found at screening to have high-risk pancreatic lesions amenable to treatment. These are defined as the following: 1. Lesions with high-grade dysplasia (HGD) 2. High-grade pancreatic intraepithelial neoplasia (PanIN) 3. Resectable or borderline resectable pancreatic cancer. Pancreatic cancers that were staged T1-3, N0-2, and M0 designated as resectable or borderline resectable. Cancers that were staged as T4 or M1 were considered locally advanced or metastatic and therefore designated as unresectable 4. Main duct intra-ductal papillary mucinous neoplasm (IPMN).This will be defined per Fukuoko guidelines as dilation of main pancreatic duct ≥ 5 mm, after duct dilation due to other causes have been excluded. 5. Branch-duct IPMN with "worrisome features". 6. Neuroendocrine tumor ≥ 2 cm.
6 secondary outcomes
Proportion of screening patients found to have high-risk pancreatic lesions
Time frame: From year 1 screening to year 12 (end of at least 5 years follow up in 2032) screening (annually)
Proportion of screening patients found to have low or moderate-risk pancreatic lesions by screening
Time frame: From year 1 to year 12 (end of at least 5 years follow up in 2032) according to the standard of care designated by GI team.
Proportion of patients undergoing screening who undergo pancreatic surgery
Time frame: From year 1 to year 12, which is the end of at least 5 years follow up in 2032.(throughout the duration of the study)
Proportion of "low yield" pancreatic surgeries performed in screening patients
Time frame: From year 1 to year 12, which is the end of at least 5 years follow up in 2032.(throughout the duration of the study)
Proportion of screening patients who undergo non-pancreatic surgery
Time frame: From year 1 to year 12 (the end of at least 5 years follow up in 2032), according to the standard of care designated by GI team
Proportion of screening patients who experience complications/adverse events of screen-related procedures
Time frame: From year 1 to year 12 (the end of at least 5 years follow up in 2032), according to standard of care designated by GI team
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 23 Apr 2026.
- BackgroundBorgida, A., Holter, S., Thomas, C., Jhaveri, K., Haider, M. A., & Gallinger, S. Screening individuals at increased risk for pancreatic cancer using biannual contrast MRI. Familial Cancer, 2017, 16 (1 Supplement 1), S108
- Background: PubMed 29803839Canto MI, Almario JA, Schulick RD, Yeo CJ, Klein A, Blackford A, Shin EJ, Sanyal A, Yenokyan G, Lennon AM, Kamel IR, Fishman EK, Wolfgang C, Weiss M, Hruban RH, Goggins M. Risk of Neoplastic Progression in Individuals at High Risk for Pancreatic Cancer Undergoing Long-term Surveillance. Gastroenterology. 2018 Sep;155(3):740-751.e2. doi: 10.1053/j.gastro.2018.05.035. Epub 2018 May 24.
- Background: PubMed 29775792Corral JE, Mareth KF, Riegert-Johnson DL, Das A, Wallace MB. Diagnostic Yield From Screening Asymptomatic Individuals at High Risk for Pancreatic Cancer: A Meta-analysis of Cohort Studies. Clin Gastroenterol Hepatol. 2019 Jan;17(1):41-53. doi: 10.1016/j.cgh.2018.04.065. Epub 2018 Jun 30.
- Background: PubMed 29683970Gangi A, Malafa M, Klapman J. Endoscopic Ultrasound-Based Pancreatic Cancer Screening of High-Risk Individuals: A Prospective Observational Trial. Pancreas. 2018 May/Jun;47(5):586-591. doi: 10.1097/MPA.0000000000001038.
- Background: PubMed 31672839Goggins M, Overbeek KA, Brand R, Syngal S, Del Chiaro M, Bartsch DK, Bassi C, Carrato A, Farrell J, Fishman EK, Fockens P, Gress TM, van Hooft JE, Hruban RH, Kastrinos F, Klein A, Lennon AM, Lucas A, Park W, Rustgi A, Simeone D, Stoffel E, Vasen HFA, Cahen DL, Canto MI, Bruno M; International Cancer of the Pancreas Screening (CAPS) consortium. Management of patients with increased risk for familial pancreatic cancer: updated recommendations from the International Cancer of the Pancreas Screening (CAPS) Consortium. Gut. 2020 Jan;69(1):7-17. doi: 10.1136/gutjnl-2019-319352. Epub 2019 Oct 31.
- Background: PubMed 33077384Kogekar N, Diaz KE, Weinberg AD, Lucas AL. Surveillance of high-risk individuals for pancreatic cancer with EUS and MRI: A meta-analysis. Pancreatology. 2020 Dec;20(8):1739-1746. doi: 10.1016/j.pan.2020.10.025. Epub 2020 Oct 9.
- BackgroundKwon, R., Dust, H., McCarthy, S., Hosmer, A., Carulli, A., Scheiman, J., . . . Stoffel, E Outcomes of pancreatic cancer surveillance in high risk individuals. American Journal of Gastroenterology, 2019, 114 (Supplement), S19.
- Background: PubMed 30309438Lachter J, Rosenberg C, Hananiya T, Khamaysi I, Klein A, Yassin K, Half E. Screening to Detect Precursor Lesions of Pancreatic Adenocarcinoma in High-risk Individuals: A Single-center Experience. Rambam Maimonides Med J. 2018 Oct 4;9(4):e0029. doi: 10.5041/RMMJ.10353.
- Background: PubMed 24840647Rahib L, Smith BD, Aizenberg R, Rosenzweig AB, Fleshman JM, Matrisian LM. Projecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the United States. Cancer Res. 2014 Jun 1;74(11):2913-21. doi: 10.1158/0008-5472.CAN-14-0155.
- Background: PubMed 31912902Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
- Background: PubMed 28735806Tanaka M, Fernandez-Del Castillo C, Kamisawa T, Jang JY, Levy P, Ohtsuka T, Salvia R, Shimizu Y, Tada M, Wolfgang CL. Revisions of international consensus Fukuoka guidelines for the management of IPMN of the pancreas. Pancreatology. 2017 Sep-Oct;17(5):738-753. doi: 10.1016/j.pan.2017.07.007. Epub 2017 Jul 13.
- Background: PubMed 30285076van Roessel S, Kasumova GG, Verheij J, Najarian RM, Maggino L, de Pastena M, Malleo G, Marchegiani G, Salvia R, Ng SC, de Geus SW, Lof S, Giovinazzo F, van Dam JL, Kent TS, Busch OR, van Eijck CH, Koerkamp BG, Abu Hilal M, Bassi C, Tseng JF, Besselink MG. International Validation of the Eighth Edition of the American Joint Committee on Cancer (AJCC) TNM Staging System in Patients With Resected Pancreatic Cancer. JAMA Surg. 2018 Dec 1;153(12):e183617. doi: 10.1001/jamasurg.2018.3617. Epub 2018 Dec 19.
- Individual participant dataSharing planned: Undecided
Related trials for Pancreatic Cancer, Adult
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingPhase 1
A Study of LY4337713 in Participants With FAP-Positive Solid Tumors
Ovarian Neoplasms, Breast Neoplasms
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08098488 in People With Advanced Solid Tumors.
Pancreatic Ductal Adenocarcinoma, Esophageal Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
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.
Mandeep Sawhney, MD,MS,FASGE principal investigator
BIDMC-Harvard Medical School
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 Cancer, Adult, 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 16 inclusion and 1 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 23 Apr 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?
Contact Roya Dastjerdi, MPH (617-667-4046, rdastjer@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of screening patients found to have high-risk pancreatic lesions amenable to treatment (time frame: From year 1 to year 12 (until the end of at least 5 years follow up in 2032), according to the standard of care designated by GI team.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05006131, which also lists 13 linked publications.
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 23 Apr 2026.