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NCT Number: NCT03060720

Systematic Hereditary Pancreatic Cancer Risk Assessment and Implications for Personalized Therapy

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2028
First posted
Feb 23, 2017
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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