Pancreatic CancerNCT02478892
Preliminary Evaluation of Screening for Pancreatic Cancer in Patients With Inherited Genetic Risk
An observational study of Pancreatic Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
The study is a prospective, observational study evaluating the utility of endoscopic ultrasound or MRI for the identification of preneoplastic and neoplastic pancreatic lesions in patients at high risk for pancreatic cancer, specifically those with BRCA1/2, ATM, or PALB2 mutations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Collection of data from endoscopic ultrasound or MRI/MRCP of the abdomen and Blood sample collection for research
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to May 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at high risk for pancreatic cancer, specifically those with pathogenic germline variant in BRCA1, BRCA2, ATM, or PALB2 who will be undergoing pancreatic cancer screening as part of their routine clinical care.
Who may be able to join
- Age >= 18
- Documented germline pathogenic or likely pathogenic BRCA1, BRCA2, ATM, or PALB2 mutation
- If no history of PDAC in a first or second degree relative, age >= 50
- If there is a history of PDAC in a first or second degree relative, minimum age of eligibility is 10 years younger than the age of onset of the youngest relative with pancreatic cancer
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bryson Katona, MD contact
United States1 site, 1 recruiting
- Recruiting
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19004
Bryson Katona, MD, 855-216-0098, Bryson.Katona@pennmedicine.upenn.edu
Bryson Katona, MD
About this study
The study is a prospective, observational study evaluating the utility of endoscopic ultrasound or MRI for the identification of preneoplastic and neoplastic pancreatic lesions in patients at high risk for pancreatic cancer, specifically those with BRCA1/2, ATM, or PALB2 mutations.
Read the detailed description
Endoscopic Ultrasound (EUS) has emerged as a critical component in the imaging, staging, and diagnosis of pancreatic cancer. Not only can EUS delineate a mass utilizing sonography through the wall of the stomach or duodenum, but it also can obtain diagnostic fine needle aspiration of suspicious lesions. Especially in patients with incomplete visualization of a mass on cross-sectional imaging, EUS can provide valuable anatomic information prior to surgical exploration. While several studies have demonstrated that EUS has high sensitivity and specificity in diagnosing pancreatic masses, head-to-head comparisons with established modalities like CT have been often methodologically flawed. In a meta-analysis, it was found that of 4 studies that assessed resectability, 2 showed no difference and 1 favored each modality. As such, estimates of accuracy for assessing preoperative resectability have also ranged in several studies from 63-93%. As such it has been recognized as an accepted modality for the evaluation of potential pancreatic malignancy.
While pancreatic ductal adenocarincoma (PDAC) screening in the general population is not feasible given the low incidence of PDAC, screening in high risk cohorts may allow for early detection of resectable, and potentially curable tumors. Clinical outcome of patients with smaller, non-metastasized tumors have a significantly improved 5-year survival. Generally the current recommendation is that patients who are first degree relatives of patients with PDAC from a familial PDAC kindred with at least 2 directly related relatives, patients with Peutz-Jeghers syndrome, those with a CDKN2A pathogenic germline variant, and those with BRCA1/BRCA2/ATM/PALB2/Lynch pathogenic germline variants with a first or second degree relative with pancreatic cancer would qualify for pancreatic cancer screening. However, there is continued debate about whether family history should be used to determine who is eligible for pancreatic cancer screening. In this study we will be following individuals at the University of Pennsylvania who have a BRCA1, BRCA2, ATM, or PALB2 pathogenic germline variant and who are getting pancreatic cancer screening, regardless of whether or not they have a family history of PDAC. Ultimately, in high-risk individuals, such as BRCA1/2, ATM, and PALB2 carriers, the successful identification of early neoplastic/preneoplastic lesions of the pancreas would allow for timely intervention and likely improved survival in this cohort.
- Conditions
- Pancreatic Cancer
- Being tested
- Collection of data from endoscopic ultrasound or MRI/MRCP of the abdomen, Blood sample collection for research
- Keywords
- high risk, specifically those with BRCA1/2 mutations
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of data from endoscopic ultrasound or MRI/MRCP of the abdomenOther
Participants in this study should be undergoing pancreatic cancer screening with endoscopic ultrasound or MRI as part of their standard care. These should typically be done at least every 12 months, and the imaging tests will be ordered as routine clinical tests and will be billed to the participant's insurance. This study does not cover the costs of these screening tests, however the study will track the results of these screening tests.
Blood sample collection for researchOther
Up to 40mL of blood may be collected for analysis at each screening examination.
What is being measured
The primary outcome is the main question the study is designed to answer.
identifying pancreatic neoplastic lesions lesions in patients with BRCA1/2 mutations and other less common, but related mutations (ATM, PALB2) as well as mutations identified in the future.
The primary objective of the study is the observational screening of patients with BRCA1/2, ATM, or, PALB2 mutations for pancreatic neoplastic lesions, to assess for both the feasibility of this approach in this high risk population as well as to better establish the incidence of these lesions in this cohort.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2028 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478892
- Sponsor's protocol ID
- UPCC 26214
- Status last verified
- Feb 2026
- First submitted
- 19 Jun 2015
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Katona BW, Long JM, Ahmad NA, Attalla S, Bradbury AR, Carpenter EL, Clark DF, Constantino G, Das KK, Domchek SM, Dudzik C, Ebrahimzadeh J, Ginsberg GG, Heiman J, Kochman ML, Maxwell KN, McKenna DB, Powers J, Shah PD, Wangensteen KJ, Rustgi AK. EUS-based Pancreatic Cancer Surveillance in BRCA1/BRCA2/PALB2/ATM Carriers Without a Family History of Pancreatic Cancer. Cancer Prev Res (Phila). 2021 Nov;14(11):1033-1040. doi: 10.1158/1940-6207.CAPR-21-0161. Epub 2021 Aug 2.
PubMed 34341011
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Evaluation of Screening for Pancreatic Cancer in Patients With Inherited Genetic Risk
- ClinicalTrials.gov ID
- NCT02478892
- Acronym / sponsor ID
- UPCC 26214
- Conditions
- Pancreatic Cancer
- Keywords
- high risk, specifically those with BRCA1/2 mutations
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 23 Jun 2015 (estimated)
- 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 study is a prospective, observational study evaluating the utility of endoscopic ultrasound or MRI for the identification of preneoplastic and neoplastic pancreatic lesions in patients at high risk for pancreatic cancer, specifically those with BRCA1/2, ATM, or PALB2 mutations.
Detailed description
Endoscopic Ultrasound (EUS) has emerged as a critical component in the imaging, staging, and diagnosis of pancreatic cancer. Not only can EUS delineate a mass utilizing sonography through the wall of the stomach or duodenum, but it also can obtain diagnostic fine needle aspiration of suspicious lesions. Especially in patients with incomplete visualization of a mass on cross-sectional imaging, EUS can provide valuable anatomic information prior to surgical exploration. While several studies have demonstrated that EUS has high sensitivity and specificity in diagnosing pancreatic masses, head-to-head comparisons with established modalities like CT have been often methodologically flawed. In a meta-analysis, it was found that of 4 studies that assessed resectability, 2 showed no difference and 1 favored each modality. As such, estimates of accuracy for assessing preoperative resectability have also ranged in several studies from 63-93%. As such it has been recognized as an accepted modality for the evaluation of potential pancreatic malignancy.
While pancreatic ductal adenocarincoma (PDAC) screening in the general population is not feasible given the low incidence of PDAC, screening in high risk cohorts may allow for early detection of resectable, and potentially curable tumors. Clinical outcome of patients with smaller, non-metastasized tumors have a significantly improved 5-year survival. Generally the current recommendation is that patients who are first degree relatives of patients with PDAC from a familial PDAC kindred with at least 2 directly related relatives, patients with Peutz-Jeghers syndrome, those with a CDKN2A pathogenic germline variant, and those with BRCA1/BRCA2/ATM/PALB2/Lynch pathogenic germline variants with a first or second degree relative with pancreatic cancer would qualify for pancreatic cancer screening. However, there is continued debate about whether family history should be used to determine who is eligible for pancreatic cancer screening. In this study we will be following individuals at the University of Pennsylvania who have a BRCA1, BRCA2, ATM, or PALB2 pathogenic germline variant and who are getting pancreatic cancer screening, regardless of whether or not they have a family history of PDAC. Ultimately, in high-risk individuals, such as BRCA1/2, ATM, and PALB2 carriers, the successful identification of early neoplastic/preneoplastic lesions of the pancreas would allow for timely intervention and likely improved survival in this cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at high risk for pancreatic cancer, specifically those with pathogenic germline variant in BRCA1, BRCA2, ATM, or PALB2 who will be undergoing pancreatic cancer screening as part of their routine clinical care.
Key inclusion criteria (4 listed)
- Age >= 18
- Documented germline pathogenic or likely pathogenic BRCA1, BRCA2, ATM, or PALB2 mutation
- If no history of PDAC in a first or second degree relative, age >= 50
- If there is a history of PDAC in a first or second degree relative, minimum age of eligibility is 10 years younger than the age of onset of the youngest relative with pancreatic cancer
Key exclusion criteria (1 listed)
- Pregnancy
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 |
|---|---|---|
| Collection of data from endoscopic ultrasound or MRI/MRCP of the abdomenParticipants in this study should be undergoing pancreatic cancer screening with endoscopic ultrasound or MRI as part of their standard care. These should typically be done at least every 12 months, and the imaging tests will be ordered as routine clinical tests and will be billed to the participant's insurance. This study does not cover the costs of these screening tests, however the study will track the results of these screening tests. | Other | – |
| Blood sample collection for researchUp to 40mL of blood may be collected for analysis at each screening examination. | Other | – |
Primary outcome
identifying pancreatic neoplastic lesions lesions in patients with BRCA1/2 mutations and other less common, but related mutations (ATM, PALB2) as well as mutations identified in the future.
Time frame: 10 years
The primary objective of the study is the observational screening of patients with BRCA1/2, ATM, or, PALB2 mutations for pancreatic neoplastic lesions, to assess for both the feasibility of this approach in this high risk population as well as to better establish the incidence of these lesions in this cohort.
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 5 Feb 2026.
- Background: PubMed 34341011Katona BW, Long JM, Ahmad NA, Attalla S, Bradbury AR, Carpenter EL, Clark DF, Constantino G, Das KK, Domchek SM, Dudzik C, Ebrahimzadeh J, Ginsberg GG, Heiman J, Kochman ML, Maxwell KN, McKenna DB, Powers J, Shah PD, Wangensteen KJ, Rustgi AK. EUS-based Pancreatic Cancer Surveillance in BRCA1/BRCA2/PALB2/ATM Carriers Without a Family History of Pancreatic Cancer. Cancer Prev Res (Phila). 2021 Nov;14(11):1033-1040. doi: 10.1158/1940-6207.CAPR-21-0161. Epub 2021 Aug 2.
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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.
Bryson Katona, MD contact
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, run by Abramson Cancer Center at Penn Medicine 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 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 5 Feb 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 Bryson Katona, MD (Bryson.Katona@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
identifying pancreatic neoplastic lesions lesions in patients with BRCA1/2 mutations and other less common, but related mutations (ATM, PALB2) as well as mutations identified in the future. (time frame: 10 years). 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 NCT02478892, which also lists 1 linked publication.
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 5 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.