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Spots Global Cancer Trial Database for Sirolimus for Improving Social Abilities in People With PTEN Germline Mutations

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Trial Identification

Brief Title: Sirolimus for Improving Social Abilities in People With PTEN Germline Mutations

Official Title: A Randomized Controlled Double-Blind Trial of Sirolimus for Improving Social Abilities in People With PTEN Germline Mutations

Study ID: NCT06080165

Interventions

Sirolimus
Placebo

Study Description

Brief Summary: The goal of this study is to examine the safety and treatment effects of sirolimus for targeting social communication deficits in people with genetic disorders associated with PTEN germline mutations, which are often referred to as PTEN Harmartoma Tumor Syndrome (PHTS). The mechanism of sirolimus in the body has shown promise for helping to improve social communication skills in case reports of people with PHTS. Everolimus, a closely related compound, also showed benefits in social communication skills in a previous pilot trial in people with PHTS. This is a 6 month double-blind trial followed by at 6 month open label extension trial.

Detailed Description:

Eligibility

Minimum Age: 5 Years

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Stanford University, Stanford, California, United States

Boston Children's Hospital, Boston, Massachusetts, United States

Cleveland Clinic, Cleveland, Ohio, United States

Contact Details

Name: Antonio Hardan, MD

Affiliation: Stanford University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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