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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 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.

CHARGE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-7 months

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

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 more

CHARGE 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,475 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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CHARGE Study: CHoice ARchitecture Genetic tEsting

Sukh Makhnoon 2024. "CHARGE Study: CHoice ARchitecture Genetic tEsting". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06284330.

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