A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2026-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pancreatic Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

MRI/MRCP

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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MRI/MRCP

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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.

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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No