Willingness to Participate in a Trial Comparing Standard Genetic Counseling Versus Personalized Genetic Counseling

NCT05126810 | Recruiting

• 2 other identifiers: 2021-0151NCI-2021-10716
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Other: Questionnaire Administration

Interventions

Questionnaire Administration OTHER

Complete questionnaire

Observational (questionnaire)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Receive receiving genetic counseling specifically for TP53 genetic testing

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M.D. Anderson Cancer Center

MeSH Terms

Conditions

Li-Fraumeni Syndrome

Condition Hierarchy (Ancestors)

Neoplastic Syndromes, Hereditary; Neoplasms; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Banu Arun

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Banu Arun

CONTACT

713-792-2360; barun@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 19, 2021
• Study Start: November 3, 2022
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): October 2, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)