Screening for pancreatic cancer in high-risk individuals
A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals
This study is testing whether regular MRI scans and blood samples can help find pancreatic cancer early in people who have a strong family history or genetic risk for the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 50 Years to 90 Years |
| Sex | All |
| Sponsor | Nuvance Health Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Norwalk, Connecticut) |
| Trial ID | NCT03250078 on ClinicalTrials.gov |
What this trial studies
This study aims to screen and detect pancreatic cancer and precursor lesions in individuals with a strong family history or genetic predisposition to the disease. Participants aged 50 and older will undergo annual MRI scans and donate blood samples for bio-bank analysis over three years. The study will utilize advanced imaging techniques, including MRI and MRCP, to identify early-stage pancreatic cancer. Any abnormalities detected will be reviewed by a multi-disciplinary tumor board and discussed with the participants.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 and older with a family history of pancreatic cancer or known genetic mutations associated with increased risk.
Not a fit: Patients without a significant family history of pancreatic cancer or those who do not carry relevant genetic mutations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of pancreatic cancer in high-risk individuals, potentially improving survival rates.
How similar studies have performed: Other studies have shown promise in early detection of pancreatic cancer using similar imaging techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Norwalk, Connecticut
- Nuvance Health — Norwalk, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Richard Frank, MD — Nuvance Health
- Study coordinator: Tammy Lo, APRN
- Email: Tammy.Lo@nuvancehealth.org
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.