RECRUITING

DS-Connect®: The Down Syndrome Registry

Conditions

Down Syndrome Patient Registry Natural History

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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 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.

Official Title

DS-Connect®: The Down Syndrome Registry

Quick Facts

Study Start:2013-09-06

Study Completion:2035-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01950624

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

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.)	* 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.

Inclusion Criteria

Exclusion 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.)

* 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.

Contacts and Locations

Study Contact

Anne Fiala

CONTACT

(303) 724-6599

info@ds-connect.org

Angela Rachubinski, PhD

CONTACT

Principal Investigator

Joaquin M Espinosa, Ph.D.

PRINCIPAL_INVESTIGATOR

Linda Crnic Institute for Down Syndrome, University of Colorado Anschutz Medical Campus

Study Locations (Sites)

Linda Crnic Institute for Down Syndrome

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Joaquin M Espinosa, Ph.D., PRINCIPAL_INVESTIGATOR, Linda Crnic Institute for Down Syndrome, University of Colorado Anschutz Medical Campus

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 Date2013-09-06

Study Completion Date2035-06

Study Record Updates

Study Start Date2013-09-06

Study Completion Date2035-06

Terms related to this study

Keywords Provided by Researchers

Patient Registry
Down Syndrome
Natural History

Additional Relevant MeSH Terms

Down Syndrome