GENetic Education Risk Assessment and TEsting Study

Summary

The goal of the GENERATE Study is to improve genetic testing and cancer prevention in family members of pancreatic cancer patients who may have genetic mutations (inherited changes). The study will measure how different methods of genetic education increase the rate of genetic testing in these families.

This is an investigational study to measure the effects of two methods of genetic education. Participants may elect to undergo genetic testing as part of the study and will be asked to provide a saliva sample via a saliva-testing kit. The genetic testing done in this study is FDA approved and will be processed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.

Up to 1,000 participants will be enrolled in this study.

Conditions

• Candidates for Hereditary Pancreatic Cancer Testing

Interventions

OTHER

Doxy.me genetic education +/- Color Genomics genetic education

Doxy.me is a HIPAA compliant telemedicine platform that allows clinicians to provide education to remote patients. Genetic education via Doxy.me will consist of a pre-recorded genetic education video and a live interactive video conferencing session with a GENERATE genetic counselor. Genetic education via Color Genomics will consist of both written information and an educational video on the Color Genomics website.

OTHER

Color Genomics genetic education

Genetic education via Color Genomics will consist of both written information and an educational video on the Color Genomics website.

Sponsors & Collaborators

• Mayo Clinic

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• Weill Medical College of Cornell University

  collaborator OTHER

• Stand Up To Cancer

  collaborator OTHER

• Lustgarten Foundation

  collaborator OTHER

• Dana-Farber Cancer Institute

  lead OTHER

Principal Investigators

• Sapna Syngal, MD, MPH · Dana-Farber Cancer Institute

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-05-08

Primary Completion

2022-12-12

Completion

2027-12-31

Countries

• United States

Study Locations