RECRUITING

Natural History Study of Individuals With Autism and Germline Heterozygous PTEN Mutations

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to determine cross-sectional and longitudinal medical, behavioral, and cognitive differences between PTEN ASD and other groups, as well as to identify cognitive, neural systems, and molecular biomarkers specific to PTEN ASD. In addition, this study will be creating and maintaining a biorepository and linked phenotypic database for PTEN ASD.

Official Title

Natural History Study of Individuals With Autism and Germline Heterozygous PTEN Mutations

Quick Facts

Study Start:2015-05
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02461446

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Rajna Filip-Dhima, MS
CONTACT
617-919-7068
Rajna.Filip-Dhima@childrens.harvard.edu

Principal Investigator

Antonio Hardan, MD
STUDY_CHAIR
Stanford University

Study Locations (Sites)

University of California at Los Angeles
Los Angeles, California, 90095
United States
Stanford University Medical Center
Stanford, California, 94305
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

  • Antonio Hardan, MD, STUDY_CHAIR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-05
Study Completion Date2026-12

Study Record Updates

Study Start Date2015-05
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • germline heterozygous PTEN mutations
  • MRI
  • 10q23.3
  • ASD
  • Autism
  • Macrocephaly
  • PTEN Hamartoma Tumor Syndrome
  • PTEN
  • EEG

Additional Relevant MeSH Terms

  • PTEN
  • ASD
  • Autism
  • Macrocephaly
  • PTEN Hamartoma Tumor Syndrome