Genetic Education for Cancer Testing

(GENERATE Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Sapna Syngal, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sapna Syngal, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

The GENERATE Study is for adults with a close relative who had pancreatic cancer and may carry certain genetic mutations. Participants must be willing to provide saliva samples, complete questionnaires, share results with their healthcare provider, and have not received recent genetic counseling or blood transfusions.

Inclusion Criteria

Individual who has signed the informed consent

Individual with a valid United States mailing address

I am 18 years old or older.

Exclusion Criteria

I am unable to sign the consent form due to a mental health condition.

I have a gene that increases my risk for cancer.

I have had genetic counseling for cancer risk in the past 3 years.

Treatment Details

Interventions

• Color Genomics genetic education (Behavioural Intervention)
• Doxy.me genetic education +/- Color Genomics genetic education (Behavioural Intervention)

Trial Overview This study tests two methods of genetic education to see if they increase the rate of genetic testing in families at risk for inherited pancreatic cancer. It involves FDA-approved testing processed in a certified lab and aims to enroll up to 1,000 participants.

Participant Groups

Group I: Doxy.me plus Color Genomics Arm (Arm 1) Experimental Treatment 1 Intervention

* Participants in this arm will receive genetic education through an online platform called Doxy.me * The Doxy.me session will consist of two parts: 1) a pre-recorded genetic education video 2) a live interactive video conferencing session with a GENERATE genetic counselor * After completing the Doxy.me session and post intervention questionnaires, participants will be directed to the Color Genomics study portal where they may elect to review Color Genomics' genetic education content or proceed directly to order genetic testing * Intervention is Doxy.me genetic education +/- genetic education via Color Genomics website

Group II: Color Genomics Only Arm (Arm 2) Experimental Treatment 1 Intervention

* Participants in this arm will access genetic education on the Color Genomics website which includes both written information and an educational video * After accessing the Color Genomics website, participants may elect to review educational content or proceed directly to order genetic testing * Intervention is genetic education via Color Genomics website

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Dr. Benjamin L. Ebert

Dana-Farber Cancer Institute

Chief Executive Officer

MD from Harvard Medical School, PhD from Oxford University

Dr. Craig A. Bunnell

Dana-Farber Cancer Institute

Chief Medical Officer since 2012

MD from Harvard Medical School, MPH from Harvard School of Public Health, MBA from MIT Sloan School of Management

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Dr. Christopher Longhurst

University of California, San Diego

Chief Medical Officer since 2021

MD and MS in Medical Informatics from UC Davis

Patty Maysent

University of California, San Diego

Chief Executive Officer since 2016

MBA from Stanford University

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

Stand Up To Cancer

Collaborator

Trials

53

Recruited

40,100+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution

Lustgarten Foundation

Collaborator

Trials

27

Recruited

5,500+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Dr. Robert Min

Weill Medical College of Cornell University

Chief Executive Officer since 2024

MD, MBA

Dr. Adam R. Stracher

Weill Medical College of Cornell University

Chief Medical Officer since 2024

MD

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine