A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals

Sponsor

Nuvance Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT03250078

Collaborator

(none)

100

Enrollment

Location

120

Duration (Months)

0.8

Patients Per Site Per Month

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
Pancreatic Neoplasms	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:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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
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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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.
Serum Bio-bank [Through study completion, up to 3 years]
Banking serum from participants to isolate circulating exosomes and circulating tumor DNA.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

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)

For FPC: The individual has at least 2 first-degree relatives (FDR) with PC.
For FPC: The individual has at least 3 first-, second-, or third-degree relatives with PC with at least 1 PC in a FDR.
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.
The individual is at least 50 years old or 10 years younger than the youngest relative with PC.
Family and genetic history confirmed by genetics counselor at WCHN.
ECOG Performance Status of 0-1.
No known contraindications to MRI examination or gadolinium contrast.
Willing to undergo MRI and screening for metal implants or metal injury.
Prior BUN and Cr
Estimated GFR (eGFR) must be greater than 40 mL/min.
Ability to provide informed consent.
Willing to return to study site for all study assessments.

Registration-Exclusion Criteria:

Prior history of pancreatic cancer.
Presence of metastatic cancer or cancer requiring adjuvant chemotherapy within the past 5 years.
Received chemotherapy within the past 6 months. (Hormonal therapy is allowable if the disease free interval is at least 5 years).
Hereditary pancreatitis.
eGFR < 40 mL/min
Contraindication to MRI examination or gadolinium contrast.
Pregnant or nursing women.
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.