Recruiting

Standard & Personalized Genetic Counseling

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05126810

Conditions

Li-Fraumeni Syndrome

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Questionnaire Administration

Study Details

Brief 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.

Conditions

Li-Fraumeni Syndrome

Study ID

NCT05126810

Start date

Nov 3, 2022

Status verified date

Apr, 2026

Completion date

Oct 2, 2027

Anticipated

Primary completion date

Feb 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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), pregnant women will also be allowed to participate
  • 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

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational (questionnaire)

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.

Interventions

Questionnaire Administration

Complete questionnaire

Primary outcome measure

  • Patient willingness to participate in a future randomized trial comparing standard genetic counseling versus personalized genetic counseling based on LFSPRO ShinyApp data [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Banu Arun

713-792-2360barun@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Banu Arun

713-792-2360barun@mdanderson.org

Principal Investigator:

Banu Arun

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-15.