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Systematic Hereditary Pancreatic Cancer Risk Assessment and Implications for Personalized Therapy

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. Read our disclaimer for details. Identifier: NCT03060720
Recruitment Status : Active, not recruiting
First Posted : February 23, 2017
Last Update Posted : March 22, 2021
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.

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Study Type : Observational
Actual Enrollment : 271 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
Actual Primary Completion Date : April 7, 2019
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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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 identifier (NCT number): NCT03060720

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United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
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Principal Investigator: Matthew B Yurgelun, MD Dana-Farber Cancer Institute
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Responsible Party: Matthew B. Yurgelun, Matthew B. Yurgelun, MD, Dana-Farber Cancer Institute Identifier: NCT03060720    
Other Study ID Numbers: 16-448
P50CA127003 ( U.S. NIH Grant/Contract )
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: March 2021
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:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases