Understanding Genetic Incidental Findings in Your Family (UNIFY Study) — UNIFY  

Familial Pancreatic Cancer Clinical Trial

Official title: Genomic Incidental Findings Disclosure (GIFD) in a Cancer Biobank: An Ethical, Legal and Social Implications (ELSI) Experiment (Protocol for Aim 3 Intervention)

Status Completed

Clinical Trial Summary

Currently, there is no clear legal or ethical guidance about how researchers and IRBs ought to proceed when the research participant in a biobank is deceased and there is clinically relevant information that could be disclosed to family members. This study is designed to test a procedure offering genetic information to family members of research participants who participated in a pancreatic cancer biobank in a Health Insurance Portability and Accountability Act (HIPAA) -compliant design.

Clinical Trial Description

To develop, prototype, and evaluate a novel procedure for offering probands' genetic results to family members. The intervention is to offer a deceased research participant's actionable germline genetic research finding, and depending upon the choice made by the next of kin, a disclosure of the research finding by a genetic counselor in a family conference call. Using mixed methods (quantitative and qualitative), the investigators will assess decision making, family communication, and actions and responses in individuals from families in which a proband is known to have a deleterious germline mutation in one of several known cancer susceptibility genes. ;

Related Conditions & MeSH terms

• Familial Pancreatic Cancer

• NCT number: NCT02560896
• Study type: Observational [Patient Registry]
• Source: Mayo Clinic
• Status: Completed
• Start date: August 2015
• Completion date: November 4, 2019