NCT03250078 A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals
| NCT ID | NCT03250078 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nuvance Health |
| Condition | Pancreatic Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2016-11 |
| Primary Completion | 2030-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2016-11 with a primary completion date of 2030-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Tammy Lo, APRN
✉ Tammy.Lo@nuvancehealth.orgRichard Frank, MD
PRINCIPAL INVESTIGATOR
Nuvance Health
Frequently Asked Questions
Who can join the NCT03250078 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 90 Years, studying Pancreatic Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03250078 currently recruiting?
Yes, NCT03250078 is actively recruiting participants. Contact the research team at Tammy.Lo@nuvancehealth.org for enrollment information.
Where is the NCT03250078 trial being conducted?
This trial is being conducted at Norwalk, United States.
Who is sponsoring the NCT03250078 clinical trial?
NCT03250078 is sponsored by Nuvance Health. The principal investigator is Richard Frank, MD at Nuvance Health. The trial plans to enroll 200 participants.