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Systematic Hereditary Pancreatic Cancer Risk Assessment and Implications for Personalized Therapy

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ClinicalTrials.gov Identifier: NCT03060720
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : February 1, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Matthew B. Yurgelun, Dana-Farber Cancer Institute

Brief Summary:
This research study is looking at people with cancer of the pancreas to find clinical factors that can explain the presence of genetic mutations

Condition or disease
Pancreatic Cancer

Detailed Description:

This research is being done to identify which pancreatic cancer patients should undergo genetic evaluation. A patient's personal and family history of cancer is the information typically used to make this decision, but there are currently no accurate, evidence-based guidelines that exist to help doctors use this information to make a decision.

The investigators hope that by testing all new pancreatic cancer patients, they can determine which clinical factors predict for genetic mutations in order to create a risk assessment tool.

The investigators want to determine which patients with pancreatic cancer will benefit from genetic testing. To do so, the investigators will offer all patients with pancreatic cancer in the Dana-Farber Gastrointestinal Oncology clinic referral for genetic evaluation. At the Cancer Genetics and Prevention clinic appointment, the provider will review the patient's personal and familial history of cancer and offer genetic testing.


Study Type : Observational
Estimated Enrollment : 375 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Systematic Hereditary Pancreatic Cancer Risk Assessment and Implications for Personalized Therapy
Actual Study Start Date : February 24, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. We will measure clinical factors (e.g. # of PDAC patients with a personal history of x,y,z; # of PDAC patients with a family history of x,y,z; # PDAC patients with a germline mutation in x,y,z) so as to develop a risk assessment tool [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. Evaluate Patient Experience With Genetic Testing [ Time Frame: up to 5 years ]
  2. Summarize patient satisfaction with Genetic counseling [ Time Frame: up to 5 years ]
  3. Number of patients who disclose genetic testing results to relatives [ Time Frame: up to 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient seen at Dana Farber Cancer Institute with a diagnosis of pancreatic ductal adenocarcinoma
Criteria

Inclusion Criteria:

  • Diagnosis of pancreatic ductal adenocarcinoma
  • Signed initial informed consent
  • Participant agrees to genetic counseling

Exclusion Criteria:

  • Prospective participant unable to sign informed consent based on referring physician recommendation.
  • Patient has neuroendocrine pancreatic tumor

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): NCT03060720


Contacts
Contact: Matthew B Yurgelun, MD 617-632-6835 matthew_yurgelun@dfci.harvard.edu
Contact: Chinedu Ukaegbu 617-632-6355 chinedu_ukaegbu@dfci.harvard.edu

Locations
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Matthew B Yurgelun, MD    617-632-6835      
Principal Investigator: Matthew B Yurgelun, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Matthew B Yurgelun, MD Dana-Farber Cancer Institute

Responsible Party: Matthew B. Yurgelun, Matthew B. Yurgelun, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03060720     History of Changes
Other Study ID Numbers: 16-448
P50CA127003 ( U.S. NIH Grant/Contract )
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Matthew B. Yurgelun, Dana-Farber Cancer Institute:
Pancreatic Cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Carcinoma
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type