Autism Spectrum DisorderNCT01452061
Evaluating the Validity of a Genetic Risk Assessment Tool in Identifying Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder and Attention Deficit/Hyperactivity Disorder, run by Thomas W. Frazier, Ph.D at 1 site in United States.
Trial summary
There are three purposes to this study. The first purpose is to evaluate the value of a genetic test in determining risk for autism spectrum disorder. Processing for genetic samples will be completed at the Cleveland Clinic using research equipment provided by IntegraGen. Read more about this study
- Who is it for?
- Ages 1 year to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Attention Deficit/Hyperactivity Disorder, Developmental Delay
- How many people
- 456 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: About 600 people will take part in this study - 300 individuals with an autism spectrum disorder, 75 individuals with attention deficit/hyperactivity disorder or another developmental or psychiatric disorder, 100 healthy siblings, and 125 unrelated individuals without a developmental or psychiatric disorder.
Who may be able to join
- Diagnosis of Autistic Disorder, Pervasive Developmental Disorder, or Asperger's Disorder or have a clinical diagnosis of another developmental or psychiatric disorder (developmental/psychiatric controls), or have no specific developmental or psychiatric diagnosis (healthy controls).
- Age 1 to 12.
Who cannot join
- For individuals with ASD and developmental concern controls, presence of a known or strongly suspected genetic disorder based on all available clinical data.
- Age less than 1 or greater than 12.
- Individuals for whom DNA is not available for analysis.
- Individuals for whom it is anticipated that they will not be available for follow-up at the Cleveland Clinic during the study period.
- Any medical diagnoses that might preclude participation in a low risk, non-interventional research study and any participant who at the discretion of the clinical investigator is not medically able to participate in the study (e.g., unable to comply with cheek swab or other procedure or has serious medical condition which precludes participation).
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Center for Autism
Cleveland, Ohio, 44104
About this study
Official title: Understanding Genetic Differences Associated With Autism Spectrum and Attention Deficit/Hyperactivity Disorder
There are three purposes to this study. The first purpose is to evaluate the value of a genetic test in determining risk for autism spectrum disorder. Processing for genetic samples will be completed at the Cleveland Clinic using research equipment provided by IntegraGen. The second purpose is to identify genetic changes that may be associated with autism spectrum disorder or attention deficit/hyperactivity disorder. The third purpose is to examine whether genetic differences and changes may predict which individuals benefit from medicine used to treat attention problems or other psychiatric difficulties.
Between 600-800 people are expected to participate in this study - approximately 300 individuals with an autism spectrum disorder, 75 individuals with attention deficit/hyperactivity disorder or another developmental or psychiatric disorder, 100 healthy siblings, and 125 unrelated individuals without a developmental or psychiatric disorder.
Read more
Study procedures will vary based upon the specific group participants are suspected to fall into (autism, attention deficit/hyperactivity disorder, psychiatric concerns/developmental delay, healthy sibling, or unrelated healthy control).
- All individuals will be asked to participate in a cheek swab (gently swabbing the inside of your cheek) to obtain cells used for genetic testing. Genetic material will be stored with identifiers such as numbers, letters or codes.
- Parents or caregivers will be asked to complete questionnaires that examine medical and family history as well as current symptoms and quality of life for the participant.
- Participants may undergo speech and language testing. This involves answering questions, looking at pictures or identifying items.
- Information recorded in participant medical records will be reviewed and collected for this study.
- Keywords
- Autism Spectrum Disorder, Attention Deficit/Hyperactivity Disorder, Developmental Delay
- Medical subject headings
- Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ASD | Participants with autism spectrum disorder. | |
| ADHD/DD | Participants with attention deficit/hyperactivity disorder, developmental delay or psychiatric disorder. | |
| Siblings | Siblings without a developmental or psychiatric disorder. | |
| Control | Unrelated individuals without a developmental or psychiatric disorder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autism Spectrum Disorder clinical diagnosis
Measured: March 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas W. Frazier, Ph.D
- Sponsor type
- University, hospital or other
- Collaborators
- IntegraGen SA
- Responsible party
- Sponsor-investigator, Thomas W. Frazier, Ph.D, The Cleveland Clinic
- Investigators
- Thomas W Frazier, Ph.D., Principal investigator, The Cleveland ClinicCharis Eng, M.D., Ph.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452061
- Sponsor's protocol ID
- CCF 11-949
- Status last verified
- Jan 2014
- First submitted
- 11 Oct 2011
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Genetic Differences Associated With Autism Spectrum and Attention Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT01452061
- Acronym / sponsor ID
- CCF 11-949
- Keywords
- Autism Spectrum Disorder, Attention Deficit/Hyperactivity Disorder, Developmental Delay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- Thomas W. Frazier, Ph.DUniversity, hospital or other
- Collaborators
- IntegraGen SA
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are three purposes to this study. The first purpose is to evaluate the value of a genetic test in determining risk for autism spectrum disorder. Processing for genetic samples will be completed at the Cleveland Clinic using research equipment provided by IntegraGen. The second purpose is to identify genetic changes that may be associated with autism spectrum disorder or attention deficit/hyperactivity disorder. The third purpose is to examine whether genetic differences and changes may predict which individuals benefit from medicine used to treat attention problems or other psychiatric difficulties.
Between 600-800 people are expected to participate in this study - approximately 300 individuals with an autism spectrum disorder, 75 individuals with attention deficit/hyperactivity disorder or another developmental or psychiatric disorder, 100 healthy siblings, and 125 unrelated individuals without a developmental or psychiatric disorder.
Study procedures will vary based upon the specific group participants are suspected to fall into (autism, attention deficit/hyperactivity disorder, psychiatric concerns/developmental delay, healthy sibling, or unrelated healthy control).
- All individuals will be asked to participate in a cheek swab (gently swabbing the inside of your cheek) to obtain cells used for genetic testing. Genetic material will be stored with identifiers such as numbers, letters or codes.
- Parents or caregivers will be asked to complete questionnaires that examine medical and family history as well as current symptoms and quality of life for the participant.
- Participants may undergo speech and language testing. This involves answering questions, looking at pictures or identifying items.
- Information recorded in participant medical records will be reviewed and collected for this study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ASD | – | –Participants with autism spectrum disorder. |
| ADHD/DD | – | –Participants with attention deficit/hyperactivity disorder, developmental delay or psychiatric disorder. |
| Siblings | – | –Siblings without a developmental or psychiatric disorder. |
| Control | – | –Unrelated individuals without a developmental or psychiatric disorder. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- About 600 people will take part in this study - 300 individuals with an autism spectrum disorder, 75 individuals with attention deficit/hyperactivity disorder or another developmental or psychiatric disorder, 100 healthy siblings, and 125 unrelated individuals without a developmental or psychiatric disorder.
Key inclusion criteria (2 listed)
- Diagnosis of Autistic Disorder, Pervasive Developmental Disorder, or Asperger's Disorder or have a clinical diagnosis of another developmental or psychiatric disorder (developmental/psychiatric controls), or have no specific developmental or psychiatric diagnosis (healthy controls).
- Age 1 to 12.
Key exclusion criteria (5 listed)
- For individuals with ASD and developmental concern controls, presence of a known or strongly suspected genetic disorder based on all available clinical data.
- Age less than 1 or greater than 12.
- Individuals for whom DNA is not available for analysis.
- Individuals for whom it is anticipated that they will not be available for follow-up at the Cleveland Clinic during the study period.
- Any medical diagnoses that might preclude participation in a low risk, non-interventional research study and any participant who at the discretion of the clinical investigator is not medically able to participate in the study (e.g., unable to comply with cheek swab or other procedure or has serious medical condition which precludes participation).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Autism Spectrum Disorder clinical diagnosis
Time frame: March 2014
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
- Cleveland Clinic Center for Autism Research WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas W Frazier, Ph.D. principal investigator
The Cleveland Clinic
Charis Eng, M.D., Ph.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Attention Deficit/Hyperactivity Disorder, run by Thomas W. Frazier, Ph.D at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autism Spectrum Disorder clinical diagnosis (time frame: March 2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2014.