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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 13, 2022
Sponsor:
Information provided by (Responsible Party):
Richard Frank, Nuvance Health

Study Description
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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.

Condition or disease Intervention/treatment
Pancreatic Neoplasms Diagnostic Test: MRI/MRCP

Detailed Description:
Individuals 50 years of age and older 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 APRN 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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals
Study Start Date : November 2016
Estimated Primary Completion Date : November 2026
Estimated Study Completion Date : November 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Diagnostic Test: MRI/MRCP
An MRI/MRCP plus IV gadolinium contrast with high resolution imaging of the pancreas will be performed annually


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Serum Bio-bank [ Time Frame: Through study completion, up to 3 years ]
    Banking serum from participants to isolate circulating exosomes and circulating tumor DNA.


Biospecimen Retention:   Samples With DNA
Serum sample

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
50-90 years of age. Strong family history of pancreatic cancer/ known genetic mutation
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 30 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 < 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250078


Contacts
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Contact: Tammy Lo, APRN Tammy.Lo@nuvancehealth.org
Contact: Pramila Krumholtz, RN Pramila.Krumholtz@nuvancehealth.org

Locations
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United States, Connecticut
Western Connecticut Health Network Recruiting
Norwalk, Connecticut, United States, 06856
Contact: Tammy Lo, APRN    203-855-3551    Tammy.Lo@nuvancehealth.org   
Contact: Pramila Krumholtz, RN    203-739-7997    Pramila.Krumholtz@nuvancehealth.org   
Principal Investigator: Richard Frank, MD         
Sponsors and Collaborators
Nuvance Health
Investigators
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Principal Investigator: Richard Frank, MD Nuvance Health
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Richard Frank, Director, Cancer Research, Nuvance Health
ClinicalTrials.gov Identifier: NCT03250078    
Other Study ID Numbers: 16-17
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: October 13, 2022
Last Verified: October 2022
Individual Participant Data (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
Informed Consent Form (ICF)
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richard Frank, Nuvance Health:
Pancreas
Cancer
MRI
 BRCA
Early Detection
Genetics
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases