A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals

April 6, 2026 updated by: Richard Frank, Nuvance Health
The main goal of this study is to screen and detect pancreatic cancer and precursor lesions in individuals with a strong family history or genetic predisposition to pancreatic cancer. Magnetic Resonance Imaging and Magnetic cholangiopancreatography (MRI/MRCP) will be utilized to screen for early stage pancreatic cancer or precursor lesions. Participants will be asked to donate a blood sample at specific intervals for the creation of a bio-bank necessary for the development of a blood based screening test for Pancreatic Cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Individuals 50 years of age and older who have a family history of pancreatic cancer will be recruited through the offices of primary care physicians and endocrinologists. Those meeting initial criteria will meet with a research APRN and will undergo a secondary screen to determine eligibility. Individuals enrolled in the study will undergo a five-minute psychological survey and donation of a blood sample for bio-bank analysis every 6 months for 3 years. MRI will be performed annually for 3 years (4 in total). Any abnormalities on MRI will be reviewed by a multi-disciplinary tumor board and discussed with the participant. The costs of MRI will be covered by the study.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

50-90 years of age. Strong family history of pancreatic cancer/ known genetic mutation

Description

Registration-Inclusion Criteria for FAMILIAL PANCREATIC CANCER (FPC) and those with a BRCA1, BRCA2, LYNCH SYNDROME, ATM, PALB2, CDKN2A, or related gene mutation (one of the following is required for questions 1-3)

  1. For FPC: The individual has at least 2 first-degree relatives (FDR) with PC.
  2. For FPC: The individual has at least 3 first-, second-, or third-degree relatives with PC with at least 1 PC in a FDR.
  3. The individual is a known mutation carrier of BRCA1, BRCA2, MLH1, MSH2, MSH6, or PMS2, ATM, PALB2, CDKN2A, or similar high-risk gene mutation and has at least 1 first- or second-degree relative with PC.
  4. The individual is at least 50 years old or 10 years younger than the youngest relative with PC.
  5. ECOG Performance Status of 0-1.
  6. No known contraindications to MRI examination or gadolinium contrast.
  7. Willing to undergo MRI and screening for metal implants or metal injury.
  8. Estimated GFR >29 mL/min
  9. Ability to provide informed consent.
  10. Willing to return to study site for all study assessments.

Registration-Exclusion Criteria:

  1. Prior history of pancreatic cancer.
  2. Presence of metastatic cancer or cancer requiring adjuvant chemotherapy within the past 5 years.
  3. Received chemotherapy within the past 6 months. (Hormonal therapy is allowable if the disease free interval is at least 5 years).
  4. Hereditary pancreatitis.
  5. eGFR < 30 mL/min
  6. Contraindication to MRI examination or gadolinium contrast.
  7. Pregnant or nursing women.
  8. Co-morbid illnesses or other concurrent disease which, in the judgment of the clinicians obtaining informed consent, would make the participant inappropriate for entry into this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
FAMILIAL PANCREATIC CANCER and/or GENE MUTATION
An inherited genetic syndrome associated with Pancreatic Cancer and/or with a strong family history of Pancreatic Cancer.
Diagnostic test: MRI/MRCP
An MRI/MRCP plus IV gadolinium contrast with high resolution imaging of the pancreas will be performed annually

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early Stage Pancreatic Cancer or Precursor Lesions
Time Frame: Through study completion, up to 3 years
Incidence of Pancreatic Cancer or precursor lesions within a population of individuals with a strong family history of pancreatic cancer or known genetic mutation compared to the expected incidence in the general population.
Through study completion, up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serial Pancreatic MRI Screening
Time Frame: Through study completion, up to 3 years
Utility of MRI as a screening tool for Pancreatic Cancer in the study population.
Through study completion, up to 3 years
Serum Bio-bank
Time Frame: Through study completion, up to 3 years
Banking serum from participants to isolate circulating exosomes and circulating tumor DNA.
Through study completion, up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nuvance Health

Investigators

  • Principal Investigator: Richard Frank, MD, Nuvance Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Estimated)

November 1, 2030

Study Completion (Estimated)

November 1, 2030

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria

August 14, 2017

First Posted (Actual)

August 15, 2017

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available.

IPD Sharing Time Frame

Data will be available within 6 months of study completion.

IPD Sharing Access Criteria

Data access requests will be reviewed on an individual basis post submission. Requestors may be required to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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