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Genetic Testing

Enhanced Genetic Testing for Cancer (CHARGE Trial)

N/A
Recruiting
Led By Sukh Makhnoon, PhD, MS
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Relative: 18 years of age or older
Proband: Have a newly reported pathogenic or likely pathogenic variant in one or more of the following genes: APC, ATM, BRCA1, BRCA2, CDH1, CHEK2, PALB2, MLH1, MSH2, MSH6, PMS2, PTEN, TP53
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-7 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing a new way of offering genetic testing to the usual method to see if it is effective.

Who is the study for?
This trial is for individuals with cancer. Specific eligibility criteria are not provided, so it's important to contact the study team for more details on who can participate.
What is being tested?
The CHARGE study is testing a new approach called 'enhanced cascade testing' against the usual care given for genetic testing in cancer patients. It aims to see if this method improves the process and outcomes of genetic testing.
What are the potential side effects?
Since this trial focuses on a genetic testing procedure rather than a drug or medical treatment, there may be no direct physical side effects. However, emotional or psychological impacts due to test results could occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I have a new genetic mutation linked to cancer in specific genes.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-7 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of cascade genetic testing
Secondary study objectives
Change in probands' family communication about genetic test results as measured by Proband survey
Family functioning as reported by probands and relatives measured by Cancer Family Impact Scale
Proband's and relative's satisfaction with decision about participating in study measured at approximately 4- 7 months
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Choice architecture cascade testingExperimental Treatment1 Intervention
Direct mailed genetic testing kit to probands' relatives.
Group II: Standard of care cascade testingActive Control1 Intervention
Standard of care cascade genetic testing

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,079 Previous Clinical Trials
1,055,904 Total Patients Enrolled
Sukh Makhnoon, PhD, MSPrincipal InvestigatorUT Southwestern Medical Center
~87 spots leftby Mar 2025
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