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Clinical Trial Record

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A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals

2016-11

2026-11

2026-11

200

Study Overview

A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals

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.

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.

  • Pancreatic Neoplasms
  • DIAGNOSTIC_TEST: MRI/MRCP
  • 16-17

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 Registration Dates Results Reporting Dates Study Record Updates

2016-11-16  

N/A  

2024-03-29  

2017-08-14  

N/A  

2024-04-01  

2017-08-15  

N/A  

2024-03  

Study Plan

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

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/ArmIntervention/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
Primary Outcome MeasuresMeasure DescriptionTime Frame
Early Stage Pancreatic Cancer or Precursor LesionsIncidence 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 MeasuresMeasure DescriptionTime Frame
Serial Pancreatic MRI ScreeningUtility of MRI as a screening tool for Pancreatic Cancer in the study population.Through study completion, up to 3 years
Serum Bio-bankBanking serum from participants to isolate circulating exosomes and circulating tumor DNA.Through study completion, up to 3 years

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

Name: Tammy Lo, APRN

Phone Number:

Email: Tammy.Lo@nuvancehealth.org

Study Contact Backup

Name: Pramila Krumholtz, RN

Phone Number:

Email: Pramila.Krumholtz@nuvancehealth.org

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
50 Years

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. 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.

Collaborators and Investigators

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

    • PRINCIPAL_INVESTIGATOR: Richard Frank, MD, Nuvance Health

    Publications

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

    General 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.
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