Germline TP53 gene testing in patients seen at the IEO

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a retrospective, observational cohort of consecutive patients referred for genetic counseling and germline TP53 testing at the Istituto Europeo di Oncologia (IEO) from 2004 to 2025. Clinical records and genetic test results will be reviewed to identify Pathogenic or Likely Pathogenic variants in TP53 and to capture the referral criteria and testing approach used. The primary endpoint is the overall detection rate of TP53 pathogenic variants among individuals referred to the institute and comparison of detection rates between subgroups defined by referral criteria and testing methods. Analyses will report frequencies, rates, and differences between groups using standard statistical methods appropriate for cohort data.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Have undergone at least one genetic counseling session at the Division of Cancer Prevention and Genetics of the IEO;
* Have undergone germline TP53 genetic testing, regardless of the referral criteria for counseling and/or testing or the approach used;
* Have provided written informed consent for participation in scientific research.

Exclusion Criteria:

* Absence of signed informed consent for participation in scientific research.

Where it's running

• Istituto Europeo di Oncologia
  Milan, Italy Recruiting

Study contacts

• Study coordinator: Mariarosaria Calvello, MD
• Email: mariarosaria.calvello@ieo.it
• Phone: +39 0294372651

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.