Systematic Hereditary Pancreatic Cancer Risk Assessment and Implications for Personalized Therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03060720

Enrollment

271

Registered

2017-02-23

Start date

2017-02-24

Completion date

2028-02-01

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer

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

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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	Up to 5 years

Secondary

Measure	Time frame
Evaluate Patient Experience With Genetic Testing	up to 5 years
Summarize patient satisfaction with Genetic counseling	up to 5 years
Number of patients who disclose genetic testing results to relatives	up to 5 years

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMatthew B Yurgelun, MD

Dana-Farber Cancer Institute

Outcome results