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A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03250078
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : October 8, 2020
Sponsor:
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.
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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