A Community-Based Pancreatic Cancer Screening Study in High-Risk Individuals: Preliminary Efficacy and Safety Results.
Jonathan Kandiah, Tammy Lo, Dugho Jin...
https://pubmed.ncbi.nlm.nih.gov/35854467Actively Recruiting
Age: 50Years - 90Years
All Genders
ID03250078
A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals
Led by Nuvance Health · Updated on 2026-04-13
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to screen for pancreatic cancer and its early signs in people aged 50 and older who have a strong family history or genetic risk for pancreatic cancer. The study focuses on using Magnetic Resonance Imaging and Magnetic cholangiopancreatography (MRI/MRCP) to detect early-stage pancreatic cancer or precursor lesions. Blood samples will also be collected to help develop a blood-based screening test for pancreatic cancer. Participants will undergo annual MRI/MRCP with IV gadolinium contrast and high-resolution imaging of the pancreas for up to 3 years, totaling four scans. Blood samples and a brief psychological survey will be collected every six months during this period. If any abnormalities appear on MRI, these will be reviewed by a multi-disciplinary tumor board and discussed with the participant. The study covers all MRI costs. Throughout the study, participants will be asked to complete surveys and provide blood samples for a bio-bank. The research team will monitor findings from MRI scans and blood tests regularly to detect early pancreatic cancer or precursor lesions. The study lasts up to three years and includes ongoing assessments to ensure participants' health and safety during this time.
CONDITIONS
Brief Title
A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals
Who Can Participate
Age: 50Years - 90Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 50 to 90 years
- Have at least 2 first-degree relatives with pancreatic cancer or at least 3 relatives including 1 first-degree relative
- Known carrier of BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, ATM, PALB2, CDKN2A or similar mutation with at least 1 first- or second-degree relative with pancreatic cancer
- ECOG Performance Status of 0-1
- No contraindications to MRI or gadolinium contrast
- Willing to undergo MRI and screening for metal implants or injuries
- Estimated glomerular filtration rate (GFR) greater than 29 mL/min
- Ability to provide informed consent
- Willing to return for all study assessments
You will not qualify if you...
- Prior history of pancreatic cancer
- Metastatic cancer or cancer requiring chemotherapy within past 5 years
- Received chemotherapy within past 6 months (hormonal therapy allowed if disease free for 5 years)
- Hereditary pancreatitis
- Estimated GFR less than 30 mL/min
- Contraindications to MRI or gadolinium contrast
- Pregnant or nursing women
- Other serious illnesses making study participation inappropriate as judged by clinicians
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Diagnostic Evaluation
Duration - 3 years
Participants undergo MRI/MRCP annually to screen for pancreatic abnormalities.
4 annual MRI visits (in-person)
Long-term Monitoring
Duration - 3 years
Participants complete a five-minute psychological survey and donate a blood sample for bio-bank analysis every 6 months.
Biannual visits every 6 months for up to 3 years
Trial Site Locations
Total: 1 location
1
Nuvance Health
Norwalk, Connecticut, United States, 06856
Actively Recruiting
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Research Team
T
Tammy Lo, APRN
P
Pramila Krumholtz, RN
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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