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Genetic Testing
Choice architecture cascade 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
CHARGE Trial 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.Check my eligibility
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.See study design
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.
CHARGE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
CHARGE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4-7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-7 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of cascade genetic testing
Secondary outcome measures
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 moreCHARGE 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
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,050 Previous Clinical Trials
1,054,099 Total Patients Enrolled
Sukh Makhnoon, PhD, MSPrincipal InvestigatorUT Southwestern Medical Center
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment for this medical study currently open and accepting participants?
"As per clinicaltrials.gov, recruitment for this trial is currently closed. The original posting date was 1st of March in the year 2024 and its most recent update was on the 27th of February in that same year. Although this particular study is not accepting new participants presently, it's worth noting that there are three alternative trials actively seeking candidates at present."
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