RECRUITING

Genome Environment Microbiome and Metabolome in Autism Study

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

GEMMA is a multicenter longitudinal observational study that follows children who are genetically at-risk of developing autism for their first three years of life, seeking to identify potential biomarkers predictive of autism development in the blood, stool, urine and saliva. The biomarkers identified in this project will contribute to a better understanding of the pathogenesis of ASD in at-risk children and possible solutions for alleviating and/or preventing ASD and ASD-related symptoms in patients in the future.

Official Title

Genome Environment Microbiome and Metabolome in Autism

Quick Facts

Study Start:2019-07-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04271774

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:Not specified to 6 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Healthy newborns and infants less than 6 months of age who have not been introduced to solid foods (elementary formula feeding is permitted)
  2. * First-degree relatives of ASD individuals (at least one sibling affected by ASD)
  1. * Infants older than 6 months of age
  2. * Inability or unwillingness of legal guardian/representative to give written informed consent

Contacts and Locations

Study Contact

Victoria Kenyon, MHA
CONTACT
617-643-4366
vakenyon@mgb.org

Principal Investigator

Alessio Fasano, MD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital for Children
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Alessio Fasano, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

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 Date2019-07-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2019-07-01
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • autism
  • microbiome
  • infants
  • pregnancy
  • genetic

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder