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RecruitingNCT03250078Updated Apr 13, 2026

A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals

An observational study in Pancreatic Neoplasms, sponsored by Nuvance Health. Recruiting at 1 site in United States. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Nuvance Health · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
50 Years to 90 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Pancreatic Neoplasms

Keywords

  • Pancreas
  • Cancer
  • MRI
  • BRCA
  • Early Detection
  • Genetics
  • ATM
  • PALB2
  • Lynch
  • CDKN2A
03

Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
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

Eligibility criteria

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

Interventions

  • Diagnostic testMRI/MRCP

    An MRI/MRCP plus IV gadolinium contrast with high resolution imaging of the pancreas will be performed annually

05

What researchers measure

Primary outcomes

  1. Early Stage Pancreatic Cancer or Precursor Lesions

    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.

    Time frame: Through study completion, up to 3 years

Secondary outcomes

  1. Serial Pancreatic MRI Screening

    Utility of MRI as a screening tool for Pancreatic Cancer in the study population.

    Time frame: Through study completion, up to 3 years

  2. Serum Bio-bank

    Banking serum from participants to isolate circulating exosomes and circulating tumor DNA.

    Time frame: Through study completion, up to 3 years

06

Study locations

1 of 1 sites recruiting
07

References and documents

Publications

  • Kandiah J, Lo T, Jin D, Melchior L, Krebs TL, Anand N, Ingram S, Krumholtz P, Pandya D, Trinidad A, Dong XE, Seshadri R, Bauman J, Lee R, Frank RC. A Community-Based Pancreatic Cancer Screening Study in High-Risk Individuals: Preliminary Efficacy and Safety Results. Clin Transl Gastroenterol. 2022 Aug 1;13(8):e00516. doi: 10.14309/ctg.0000000000000516. Epub 2022 Jul 20. PubMed 35854467 ↗

Individual participant data

Plan to share: Yes — De-identified individual participant data for all primary and secondary outcome measures will be made available.

Supporting information: Study protocol, Icf, Csr

08

Registry details

Key details

Study ID
NCT03250078
Lead sponsor
Nuvance Health
Responsible party
Richard Frank (Director, Cancer Research, Nuvance Health) — Principal investigator
First posted
Aug 15, 2017
Start date
Nov 2016
Primary completion
Nov 2030 (estimated)
Completion
Nov 2030 (estimated)
Last update
Apr 13, 2026

Study contacts

Tammy Lo, APRN
Contact
Tammy.Lo@nuvancehealth.org
Pramila Krumholtz, RN
Contact
Pramila.Krumholtz@nuvancehealth.org
Richard Frank, MD
principal investigator · Nuvance Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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