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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05126810
Other study ID # 2021-0151
Secondary ID NCI-2021-1071620
Status Recruiting
Phase
First received
Last updated
Start date November 3, 2022
Est. completion date October 2, 2027

Study information

Verified date April 2024
Source M.D. Anderson Cancer Center
Contact Banu Arun
Phone 713-792-2360
Email barun@mdanderson.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates patients willingness to participate in a trial comparing standard genetic counseling versus personalized genetic counseling. Collecting information from patients may help researchers learn why patients may or may not take part in the future study that compares standard genetic counseling to personalized genetic counseling.


Description:

PRIMARY OBJECTIVE: I. To evaluate patients' willingness to participate in a future randomized trial comparing standard genetic counseling versus personalized genetic counseling based on Li-Fraumeni syndrome patient reported outcome (LFSPRO) ShinyApp data. OUTLINE: Patients complete a questionnaire over 15-20 minutes. Patients positive for a TP53 mutation complete an additional questionnaire over 15-20 minutes within 1 month after test results.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date October 2, 2027
Est. primary completion date February 2, 2027
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Individuals age 15 or older OR parent/guardian of a patient younger than 15 years (if age 15-17, the patient will provide assent and parent/guardian will provide consent) - English fluency - Receive genetic counseling specifically for TP53 genetic testing and who consent to undergo TP53 genetic testing OR individuals whose genetic testing indicates a TP53 germline mutation Exclusion Criteria: - Individuals who are non-English speaking - Individuals having low suspicion for a TP53 germline mutation during pretest counseling and test negative for a TP53 mutation

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire Administration
Complete questionnaire

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient willingness to participate in a future randomized trial comparing standard genetic counseling versus personalized genetic counseling based on LFSPRO ShinyApp data Through study completion, an average of 1 year
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