AutismSAGANCT01716845
SynapDx Autism Gene Expression Analysis Study
An observational study of Autism, run by SynapDx at 1 site in United States.
Trial summary
This study will prospectively enroll approximately 660 children, at least 18 months and less than 5 years of age, who have been referred to a pediatric developmental evaluation centers. Read more about this study
- Who is it for?
- Ages 18 months to 5 years
- Conditions the study is for
- Autism
- How many people
- 660 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Dec 2014
- 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 18 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children 18 months to < 5 years referred to a developmental evaluation centers for evaluation of a possible developmental disorder.
Who may be able to join
- Referred to a developmental evaluation centers for evaluation of a possible developmental disorder, other than isolated motor problems.
- Age >= 18 months and < 5 years.
- Parent/legal guardian has been informed about the study and has signed an informed consent form.
Who cannot join
- Prior reliable diagnosis of Autism Spectrum Disorder (i.e. prior evaluation by a multi-disciplinary team has already reliably established Autism Spectrum Disorder diagnosis).
- Unable or unwilling to complete study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: SynapDx Autism Spectrum Disorder Gene Expression Analysis Study
This study will prospectively enroll approximately 660 children, at least 18 months and less than 5 years of age, who have been referred to a pediatric developmental evaluation centers. Enrolled children will have blood drawn for RNA gene expression analysis and undergo a clinical evaluation to determine the presence or absence of a diagnosis of ASD.
The sequential co-primary objectives of this study are:
- To develop an algorithm to classify blood RNA gene expression patterns to maximize agreement between the classification and a clinical assessment of presence or absence of Autism Spectrum Disorders (ASD).
- To prospectively assess the clinical sensitivity and specificity of the blood RNA gene expression classification algorithm (the SDX-002 test) in children referred to a developmental evaluation clinic for a possible developmental disorder.
- Conditions
- Autism
- Keywords
- autism, autism spectrum disorders, RNA, gene expression, developmental delay
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, 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 |
|---|---|---|
| Development group 1 | Not described | |
| Development group 2 | Not described | |
| Development group 3 | Not described | |
| Validation group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
RNA gene expression in peripheral blood
Measured: within 30 days of collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SynapDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716845
- Sponsor's protocol ID
- 12001
- Acronym
- SAGA
- Status last verified
- Dec 2014
- First submitted
- 23 Oct 2012
- Last updated
- 17 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SynapDx Autism Spectrum Disorder Gene Expression Analysis Study
- ClinicalTrials.gov ID
- NCT01716845
- Acronym / sponsor ID
- SAGA / 12001
- Conditions
- Autism
- Keywords
- autism, autism spectrum disorders, RNA, gene expression, developmental delay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- SynapDxIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Oct 2012 (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.
This study will prospectively enroll approximately 660 children, at least 18 months and less than 5 years of age, who have been referred to a pediatric developmental evaluation centers. Enrolled children will have blood drawn for RNA gene expression analysis and undergo a clinical evaluation to determine the presence or absence of a diagnosis of ASD.
The sequential co-primary objectives of this study are:
- To develop an algorithm to classify blood RNA gene expression patterns to maximize agreement between the classification and a clinical assessment of presence or absence of Autism Spectrum Disorders (ASD).
- To prospectively assess the clinical sensitivity and specificity of the blood RNA gene expression classification algorithm (the SDX-002 test) in children referred to a developmental evaluation clinic for a possible developmental disorder.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Development group 1 | – | – |
| Development group 2 | – | – |
| Development group 3 | – | – |
| Validation group | – | – |
Who may qualify
- Ages
- 18 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children 18 months to < 5 years referred to a developmental evaluation centers for evaluation of a possible developmental disorder.
Key inclusion criteria (3 listed)
- Referred to a developmental evaluation centers for evaluation of a possible developmental disorder, other than isolated motor problems.
- Age >= 18 months and < 5 years.
- Parent/legal guardian has been informed about the study and has signed an informed consent form.
Key exclusion criteria (2 listed)
- Prior reliable diagnosis of Autism Spectrum Disorder (i.e. prior evaluation by a multi-disciplinary team has already reliably established Autism Spectrum Disorder diagnosis).
- Unable or unwilling to complete study procedures
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
RNA gene expression in peripheral blood
Time frame: within 30 days of collection
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 17 Dec 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by SynapDx 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 3 inclusion and 2 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 17 Dec 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?
RNA gene expression in peripheral blood (time frame: within 30 days of collection). 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 17 Dec 2014.