A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals
ConditionPancreatic Neoplasms
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-90
SponsorNuvance Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
50-90 years of age. Strong family history of pancreatic cancer/ known genetic mutation
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
MRI/MRCP
Diagnostic testAn MRI/MRCP plus IV gadolinium contrast with high resolution imaging of the pancreas will be performed annually
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: FAMILIAL PANCREATIC CANCER and/or GENE MUTATION1 intervention
Trial outcomes
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 yearsSecondary 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 years2
Serum Bio-bank
Banking serum from participants to isolate circulating exosomes and circulating tumor DNA.
Time frame
Through study completion, up to 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov