A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals

Nuvance Health (Other)
Overall Status
CT.gov ID

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: MRI/MRCP

Detailed Description

Individuals between 50-80 years of age 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 nurse 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 Design

Study Type:
Anticipated Enrollment :
100 participants
Observational Model:
Time Perspective:
Official Title:
A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals
Study Start Date :
Nov 1, 2016
Anticipated Primary Completion Date :
Nov 1, 2026
Anticipated Study Completion Date :
Nov 1, 2026

Arms and Interventions

Arm Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

  1. Early Stage Pancreatic Cancer or Precursor Lesions [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.

Secondary Outcome Measures

  1. Serial Pancreatic MRI Screening [Through study completion, up to 3 years]

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

  2. Serum Bio-bank [Through study completion, up to 3 years]

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

Eligibility Criteria


Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:

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. Family and genetic history confirmed by genetics counselor at WCHN.

  6. ECOG Performance Status of 0-1.

  7. No known contraindications to MRI examination or gadolinium contrast.

  8. Willing to undergo MRI and screening for metal implants or metal injury.

  9. Prior BUN and Cr

  10. Estimated GFR (eGFR) must be greater than 40 mL/min.

  11. Ability to provide informed consent.

  12. 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 < 40 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.

Contacts and Locations


Site City State Country Postal Code
1 Western Connecticut Health Network Norwalk Connecticut United States 06856

Sponsors and Collaborators

  • Nuvance Health


  • Principal Investigator: Richard Frank, MD, Nuvance Health

Study Documents (Full-Text)

None provided.

More Information

Additional Information:


None provided.
Responsible Party:
Richard Frank, Director, Cancer Research, Nuvance Health
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • 16-17
First Posted:
Aug 15, 2017
Last Update Posted:
Oct 8, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Richard Frank, Director, Cancer Research, Nuvance Health
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2020