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Genetic Education for Cancer Testing (GENERATE Trial)

N/A

Waitlist Available

Led By Sapna Syngal, MD, MPH

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individual who is 18 years or older

Individual with a first-degree relative who has (or had) pancreatic ductal adenocarcinoma (PDAC) OR a second-degree relative who has (or had) PDAC and has a known germline mutation in APC, ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2, PMS2, STK11, or TP53. The germline mutation and history of PDAC must be on the maternal side or paternal side of the individual's family

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

GENERATE Trial Summary

This trial is looking at how to best educate people about genetic testing for cancer in order to increase the rate of testing in families with a history of the disease. Participation involves either completing an educational module or being part of a focus group, and may also include genetic testing.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial focuses on education and genetic testing rather than medication or invasive procedures, it does not involve typical medical side effects. However, learning about one's genetic risks can have emotional or psychological impacts.

GENERATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have a family history of pancreatic cancer and a known genetic mutation.

GENERATE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change of genetic testing among family members of mutation positive PDAC patients, among family members of mutation positive individuals with a family history of PDAC and among first-degree relatives of PDAC patients

Secondary outcome measures

Degree of family communication about genetic test results

Factors in decision making

Increase of knowledge of genetic testing

+2 more

GENERATE Trial Design

2Treatment groups

Experimental Treatment

Group I: Doxy.me plus Color Genomics Arm (Arm 1)Experimental Treatment1 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 Treatment1 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San DiegoOTHER

1,121 Previous Clinical Trials

1,519,924 Total Patients Enrolled

M.D. Anderson Cancer CenterOTHER

2,973 Previous Clinical Trials

1,788,346 Total Patients Enrolled

Stand Up To CancerOTHER

51 Previous Clinical Trials

39,294 Total Patients Enrolled

Media Library

Pancreatic Cancer Testing Clinical Trial 2023: Color Genomics genetic education Highlights & Side Effects. Trial Name: NCT03762590 — N/A

Color Genomics genetic education 2023 Treatment Timeline for Medical Study. Trial Name: NCT03762590 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants still being enrolled in this clinical experiment?

"The latest update on clinicaltrials.gov confirms that this medical study, which was posted initially on 8th May 2019 and last updated 21st November 2022, is not actively recruiting any more participants. However, there are presently 583 other trials in need of enrollees."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

GENetic Education Risk Assessment and TEsting Study

Sapna Syngal, MD, MPH 2019. "GENetic Education Risk Assessment and TEsting Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03762590.