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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 : Active, not recruiting
First Posted : February 23, 2017
Last Update Posted : March 22, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Matthew B. Yurgelun, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date February 15, 2017
First Posted Date February 23, 2017
Last Update Posted Date March 22, 2021
Actual Study Start Date February 24, 2017
Actual Primary Completion Date April 7, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 17, 2017)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 17, 2017)
  • Evaluate Patient Experience With Genetic Testing [ Time Frame: up to 5 years ]
  • Summarize patient satisfaction with Genetic counseling [ Time Frame: up to 5 years ]
  • Number of patients who disclose genetic testing results to relatives [ Time Frame: up to 5 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Systematic Hereditary Pancreatic Cancer Risk Assessment and Implications for Personalized Therapy
Official Title Systematic Hereditary Pancreatic Cancer Risk Assessment and Implications for Personalized Therapy
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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patient seen at Dana Farber Cancer Institute with a diagnosis of pancreatic ductal adenocarcinoma
Condition Pancreatic Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: March 4, 2020)
271
Original Estimated Enrollment
 (submitted: February 17, 2017)
375
Estimated Study Completion Date February 2022
Actual Primary Completion Date April 7, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03060720
Other Study ID Numbers 16-448
P50CA127003 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Matthew B. Yurgelun, Dana-Farber Cancer Institute
Study Sponsor Dana-Farber Cancer Institute
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Matthew B Yurgelun, MD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date March 2021