Clinical Trial: DS-Connect {TM}: The Down Syndrome Registry

Study Status: Suspended
Recruit Status: Suspended
Study Type: Observational

Official Title: DS-Connect [TM]: The Down Syndrome Registry

Brief Summary:

Objective: The development of a patient registry for Down syndrome (DS) was identified as a priority in the 2007 Down Syndrome Research Plan. Under the auspices of the Down Syndrome Consortium, founded in 2011 as a public-private partnership between the NIH and DS advocacy organizations, NICHD awarded a contract in 2012 to create a patient-focused online registry to facilitate research participation by individuals with DS. Two advisory boards, composed of advocates, family members, clinicians, researchers, and other relevant parties, have been involved in the development of the registry materials.

Study Population: Individuals with DS (including those with mosaic DS and partial trisomy 21)

Design: DS-Connect (TM) is an online survey tool designed to collect demographic data and health information from individuals with DS.

Outcome measures: The purposes of DS-Connect (TM) are:

  1. To identify the various phenotypic manifestations of DS.
  2. To identify individuals with DS who may be eligible for research studies or new clinical trials, based on specific information about their diagnosis and health history.

Detailed Summary:

Objective: The development of a patient registry for Down syndrome (DS) was identified as a priority in the 2007 Down Syndrome Research Plan. Under the auspices of the Down Syndrome Consortium, founded in 2011 as a public-private partnership between the NIH and DS advocacy organizations, NICHD awarded a contract in 2012 to create a patient-focused online registry to facilitate research participation by individuals with DS. Two advisory boards, composed of advocates, family members, clinicians, researchers, and other relevant parties, have been involved in the development of the registry materials.

Study Population: Individuals with DS (including those with mosaic DS and partial trisomy 21)

Design: DS-Connect (TM) is an online survey tool designed to collect demographic data and health information from individuals with DS.

Outcome measures: The purposes of DS-Connect (TM) are:

  1. To identify the various phenotypic manifestations of DS.
  2. To identify individuals with DS who may be eligible for research studies or new clinical trials, based on specific information about their diagnosis and health history.

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Current Primary Outcome:

  • To identify individuals with DS who may be eligible for research studies or new clinical trials, based on specific information about their diagnosis and health history. [ Time Frame: 1 year ]
  • To determine the prevalence and various phenotypic manifestations of DS. [ Time Frame: 1 year ]


Original Primary Outcome: Methothelioma Sample Acquisition [ Time Frame: 20 years ]

Current Secondary Outcome:

  • Aggregate data from individuals with DS globally. Enable researchers to use de-identified data to analyze the etiology, natural history, and/or treatment effectiveness in DS. Help medical professionals improve treatments for those with DS. [ Time Frame: 1 year ]
  • Study why individuals with DS have different symptoms. Allow individuals with DS and their families to look at their information in DS-Connect and compare it to de-identified information from other participants in the Registry. [ Time Frame: 1 year ]


Original Secondary Outcome:

Information By: National Institutes of Health Clinical Center (CC)

Dates:
Date Received: September 21, 2013
Date Started: September 5, 2013
Date Completion: August 16, 2018
Last Updated: April 21, 2017
Last Verified: February 27, 2017