A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals

• ClinicalTrials.gov Identifier: NCT03250078
• Recruitment Status: Recruiting
• First Posted: August 15, 2017
• Last Update Posted: October 8, 2020
• Sponsor: Nuvance Health
• Information provided by (Responsible Party): Richard Frank, Nuvance Health

Tracking Information

• First Submitted Date: November 16, 2016
• First Posted Date: August 15, 2017
• Last Update Posted Date: October 8, 2020
• Study Start Date: November 2016
• Estimated Primary Completion Date: November 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 5, 2019)

Early Stage Pancreatic Cancer or Precursor Lesions [ Time Frame: 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.

Original Primary Outcome Measures (submitted: August 14, 2017)

Early Stage Pancreatic Cancer or Precursor Lesions [ Time Frame: Through study completion, up to 3 years ]

Incidence of Pancreatic Cancer or precursor lesions within a population of new-onset diabetes mellitus individuals, as well as, in individuals with a strong family history of pancreatic cancer or known genetic mutation compared to the expected incidence in the general population.

Current Secondary Outcome Measures (submitted: August 14, 2017)

• Serial Pancreatic MRI Screening [ Time Frame: Through study completion, up to 3 years ]
  Utility of MRI as a screening tool for Pancreatic Cancer in the study population.
• Serum Bio-bank [ Time Frame: Through study completion, up to 3 years ]
  Banking serum from participants to isolate circulating exosomes and circulating tumor DNA.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals
• Official Title: A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals
• 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.
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Serum sample

• Sampling Method: Non-Probability Sample
• Study Population: 50-80 years of age. Strong family history of pancreatic cancer/ known genetic mutation
• Condition: Pancreatic Neoplasms

Intervention

Diagnostic Test: MRI/MRCP

An MRI/MRCP plus IV gadolinium contrast with high resolution imaging of the pancreas will be performed annually

Study Groups/Cohorts

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.

Intervention: Diagnostic Test: MRI/MRCP

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 5, 2019): 100
• Original Estimated Enrollment (submitted: August 14, 2017): 800
• Estimated Study Completion Date: November 2026
• Estimated Primary Completion Date: November 2026 (Final data collection date for primary outcome measure)

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. Family and genetic history confirmed by genetics counselor at WCHN.
6. ECOG Performance Status of 0-1.
7. No known contraindications to MRI examination or gadolinium contrast.
8. Willing to undergo MRI and screening for metal implants or metal injury.
9. Prior BUN and Cr
10. Estimated GFR (eGFR) must be greater than 40 mL/min.
11. Ability to provide informed consent.
12. 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 < 40 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Tammy Lo, APRN; Tammy.Lo@wchn.org

Contact: Pramila Krumholtz, RN; Pramila.Krumholtz@wchn.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03250078
• Other Study ID Numbers: 16-17
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
• Supporting Materials: Study Protocol
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: Data access requests will be reviewed on an individual basis post submission. Requestors may be required to sign a data access agreement.

• Responsible Party: Richard Frank, Nuvance Health
• Study Sponsor: Nuvance Health
• Collaborators: Not Provided

Investigators

• Principal Investigator: Richard Frank, MD; Nuvance Health

• PRS Account: Nuvance Health
• Verification Date: October 2020