Evaluating willingness to participate in genetic counseling comparison
Official title: Evaluate Willingness to Participate in a Trial Comparing Standard Genetic Counseling Versus Personalized Genetic Counseling Based on LFSPRO-ShinyApp Data
Run by M.D. Anderson Cancer Center · NCT05126810 · Data updated 2026-11-12
This study is trying to see how willing people with Li-Fraumeni syndrome are to join a future trial comparing regular genetic counseling to personalized genetic counseling.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | November 3, 2022 |
| Main results expected | February 2, 2027 |
| Study ends | October 2, 2027 |
| Registry record updated | October 7, 2026 |
| Trial ID | NCT05126810 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged 15 or older who are receiving genetic counseling for TP53 genetic testing or have a confirmed TP53 germline mutation.
✕Probably not a fit
Patients who are non-English speaking or have a low suspicion for a TP53 mutation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study assesses patients' willingness to participate in a future trial that compares standard genetic counseling with personalized genetic counseling for individuals affected by Li-Fraumeni syndrome. Participants will complete a questionnaire that takes approximately 15-20 minutes, with additional questions for those who test positive for a TP53 mutation. The goal is to gather insights on patient preferences and motivations regarding genetic counseling options, which may inform future research designs.
Why it matters
Potential benefit: If successful, this study could enhance understanding of patient preferences in genetic counseling, leading to improved counseling approaches.
How similar studies have gone: While this approach is focused on patient willingness, similar studies have shown success in understanding patient preferences in genetic counseling.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
M D Anderson Cancer Center
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Banu Arun — M.D. Anderson Cancer Center
- Study coordinator: Banu Arun
- Email: barun@mdanderson.org
- Phone: 713-792-2360
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using video capsules to examine patients with Lynch Syndrome
This study is testing whether video capsules can be a good alternative to regular colonoscopies for people with Lynch Syndrome to help improve cancer screening.
-
Understanding genetic causes of neuroendocrine tumors in Mexican patients
This study is trying to find out the genetic changes that cause neuroendocrine tumors in Mexican patients to help develop better treatments.
-
Using arsenic trioxide with chemotherapy to treat pediatric cancer with p53 mutations
This study is testing if adding arsenic trioxide to chemotherapy can help children with Li-Fraumeni syndrome and p53 mutations fight their cancer more safely.
-
Registry for Li Fraumeni and Li Fraumeni-Like Syndromes
This study is creating a registry to gather information from people with Li-Fraumeni and Li-Fraumeni-Like Syndromes to help understand these conditions better and improve diagnosis and research.
-
Understanding Li-Fraumeni Syndrome and TP53 Variants
This study is trying to understand cancer risks in people with Li-Fraumeni Syndrome or TP53 gene changes to help improve prevention and treatment options.
-
Biobank for patients with Li-Fraumeni Syndrome and TP53 mutations
This study is collecting health information and samples from people with Li-Fraumeni Syndrome and TP53 mutations, as well as their family members, to see how their genes affect cancer risk and to find better ways to screen for and treat these cancers.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.