Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT01950624

Conditions

Down Syndrome

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The goal of this study is to develop a registry for Down syndrome (DS) to facilitate research participation by individuals with Down syndrome.

DS-Connect® is an online survey tool designed to collect demographic data and health information from individuals with DS. It is open to all people with Down syndrome.

The purposes of DS-Connect® 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.

Conditions

Down Syndrome

Study ID

NCT01950624

Start date

Sep 6, 2013

Status verified date

Jan, 2025

Completion date

Jun, 2035

Anticipated

Primary completion date

Jun, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

INCLUSION CRITERIA:

  • Adults (at least 18 years of age) with a diagnosis of DS (including mosaic DS or partial trisomy 21) who are capable of providing consent to participate, or for whom a legally authorized representative (LAR) may give permission on behalf of the individual to participate. Adults with DS who cannot consent for themselves but can provide assent would need to provide assent to their LAR.
  • Children (up to age 18 years of age) with a diagnosis of DS. Parents/guardians may enter registry information and give permission to participate on behalf of their child; if the child is over 7 years of age and able to provide assent, they must do so. (Note: Once a child has reached age 18, he or she will be prompted to re-enroll into the registry as an adult, if he/she is able to provide informed consent or with the consent of his/her LAR if unable to re-enroll themselves.)

No individuals with DS will be excluded from taking part in DS-Connect based on age, race, ethnicity, or gender.

EXCLUSION CRITERIA:

  • A person who does not have a diagnosis of DS (or mosaic DS or partial trisomy 21)
  • Adults with DS who are not capable of providing informed consent or assent to participate and do not have a Legally Authorized Representative who can do so. In the case where an adults with DS is able to provide assent but does not do so, that adult will be excluded.
  • A participant, parent, and/or LAR who cannot provide consent or does not read or understand a language that is available for the registry, either English or Spanish.
  • A child with DS (between the ages of 7 and 18 years) who is capable of providing assent but does not do so.
  • A child under the age of 18 years whose parents share joint custody and one parent indicates that they do not consent to the child's participation.

Study Design

Enrollment

100000 participants

Anticipated

Interventions and Outcome Measures

Arms

Down syndrome cohort

Individuals who have a diagnosis of complete trisomy 21, translocation Down syndrome or mosaic Down syndrome.

Primary outcome measure

  • To determine the prevalence of the various co-occurring conditions in Down syndrome. [ Time Frame: Through study completion, up to 10 years ]
  • Facilitate participation in research for individuals with DS who may be eligible for research studies or new clinical trials. [ Time Frame: Through study completion, up to 10 years ]

Central Contacts and Locations

Central contacts

Anne Fiala

(303) 724-6599info@ds-connect.org

Locations

Linda Crnic Institute for Down Syndrome

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Anne Fiala

303-724-6599info@ds-connect.org

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jan 31, 2025

Last verified

Jan, 2025

Keywords

  • Patient Registry
  • Down Syndrome
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-01-31.