Autism Spectrum DisorderMAPNCT04672967
MAP Autism Prediction Study
An observational study of Autism Spectrum Disorder and Developmental Delay, run by BioROSA Technologies Inc at 1 site in United States.
Trial summary
This pilot clinical trial tests the hypothesis that certain blood metabolite levels can be used to predict Autism Spectrum Disorder (ASD). The study cohort will consist of 200 participants between the ages 18 and 60 months who have been referred to a developmental pediatric center for clinical evaluation of ASD or… Read more about this study
- Who is it for?
- Ages 18 to 60 months
- Conditions the study is for
- Autism Spectrum Disorder, Developmental Delay
- What is being tested?
- BioROSA MAP test
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2021to Oct 2022
- 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 to 60 months
- All sexes
- Child
Study population: Up to 250 participants, ages 18-60 months suspected of ASD or a developmental delay who are referred for evaluation at participating pediatric developmental centers.
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- 18-60 months of age
- Primary language is English (this is due to the evaluation instruments being used, which are in the English language).
- Suspected developmental concern and referral to the developmental center by child's physician
- Parental informed consent to participate in the study (based on the age range of the children in this study, assent is being waived)
- Willingness to comply with all study procedures
- Not currently enrolled in another clinical trial
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Previous diagnosis of ASD or DD
- Prematurity < 34 weeks' gestation
- Has a sibling already enrolled in the trial
- Profound sensory deficits (e.g., hearing and vision deficits) that could interfere with the interpretation of study results
- Documented current or active seizures, as defined by a clinical seizure or abnormal EEG within the past six months
Show all 14Show fewer
- Major genetic defect as determined by chromosomal microarray or other method of genetic detection
- Currently taking any high dose (greater than recommended daily allowance) dietary supplements
- Diagnosis or suspicion of recent viral/bacterial infection within 2 weeks of enrollment
- Diagnosis with congenital brain malformations, moderate to severe traumatic brain injury, congenital or acquired microcephaly, or infection of the central nervous system (e.g., meningitis, viral encephalitis)
- Fetal alcohol syndrome, Down syndrome, or another recognized syndrome
- Usage of acetaminophen (e.g., Tylenol) within the past 72 hours
- Fever (temperature > 100 degrees Fahrenheit) within the past 72 hours
- Any other reason that the clinical investigator feels may place the participant at an unnecessary risk to participate
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
VUMC
Nashville, Tennessee, 37212
Sarah Marler, 615-936-3288, sarah.marler@vumc.org
Caroline Roof, (615) 936-3288, caroline.roof@vumc.org
About this study
Official title: Metabolic Autism Prediction (MAP) Study
This pilot clinical trial tests the hypothesis that certain blood metabolite levels can be used to predict Autism Spectrum Disorder (ASD). The study cohort will consist of 200 participants between the ages 18 and 60 months who have been referred to a developmental pediatric center for clinical evaluation of ASD or other developmental delay. Two selected sites will enroll 75 participants each with another 50 typically developing participants. Participants will receive a physical exam (including a dysmorphology evaluation), ADOS, VABS, MSEL, DSM-5, and M-CHAT assessments, and receive a diagnosis. A fasting blood draw is required, consisting of 2 mL vacutainer tubes (max 4 mL). Sites must process blood according to sponsor requirements (outlined in the Sponsor's Laboratory Manual). Certain metabolite levels in the blood will be used for diagnostic screening test development.
Read the detailed description
The primary objective is to conduct a double-blind, proof-of-concept, two-site, prospective study of 200 children aged 18-60 months that have been referred for an ASD evaluation by a physician to assess the feasibility of a blood test that measures a set of blood plasma metabolites and the classification algorithm developed thereof to predict the risk of ASD.
The secondary objective is to collect additional information for sub-classification of participant cohorts including Vineland Adaptive Behavior Scale (VABS) and Mullen Scale of Early Learning (MSEL) as well as any comorbidities that may correlate with blood test scores.
- Conditions
- Autism Spectrum Disorder, Developmental Delay
- Being tested
- BioROSA MAP test
- Medical subject headings
- Autism Spectrum Disorder, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioROSA MAP testDiagnostic test
The BioROSA MAP test is a blood test that is being developed to predict ASD risk
| Study group | Role | What they receive |
|---|---|---|
| Autism Spectrum Disorder | Children diagnosed with ASD between the ages of 18-60 months Receives: Diagnostic Test: BioROSA MAP test | |
| Non-ASD (developmental delay or typically developing) | Children diagnosed with non-ASD between the ages of 18-60 months Receives: Diagnostic Test: BioROSA MAP test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autism Diagnostic Observation Scale (ADOS)
The Autism Diagnostic Observation Schedule (ADOS) is considered a gold-standard instrument for diagnosing and assessing autism with good diagnostic sensitivity and specificity in young children (37). The ADOS consists of a series of structured and semi-structured tasks that involve social interaction between the examiner and the person under assessment. The examiner observes and identifies segments of the subject's behavior and assigns these to predetermined observational categories. Categorized observations are subsequently combined to produce quantitative scores for analysis and diagnostic classification of ASD. Children at or above predetermined cutoff lines are considered to be positive for ASD.
Measured: 1 day (At study entry (one time evaluation))
Secondary outcomes (3)
Vineland Adaptive Behavior Scale (VABS)
Vineland Adaptive Behavior Scale (VABS). The Vineland Adaptive Behavior Scale (VABS) will measure functional abilities within several domains including communication, daily living skills, socialization, and motor skills. The VABS has been used widely in ASD assessments and provides a measure of core symptoms and adaptive function across a wide age range (38). All sections of the VABS up through physical activity "using small muscles" will be completed. Subsequent sections consisting of problem behaviors will not be completed, as these are not needed to obtain an adaptive behavior composite score.
Measured: 1 day (At study entry (one time evaluation))
Mullen Scales of Early Learning (MSEL)
The Mullen Scales of Early Learning (MSEL) is a measure of cognitive functioning for infants and preschool-age children from birth through age 68 months. The MSEL is organized into 5 subscales: (a) gross motor, (b) fine motor, (c) visual reception (or non-verbal problem solving), (d) receptive language, and (e) expressive language. An early learning composite score can be derived from fine motor, visual reception, receptive language, and expressive language scales. For young children this early learning composite score is considered equivalent to a more traditional "IQ" score or a developmental standard score (38). Each subscale is standardized to calculate a standard score, percentile, and age-equivalent score.
Measured: 1 day (At study entry (one time evaluation))
Modified Checklist for Autism in Toddlers (M-CHAT)
The M-CHAT is a 23 question (yes/no) parent-completed screening measure for ASD. The M-CHAT is a routinely used level 1 screening instrument for ASD and is recommended for universal screening for ASD at 18- and 24-month well baby visits by the American Academy of Pediatrics (AAP)
Measured: 1 day (At study entry (one time evaluation))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start3 Nov 2021
- Primary completionMay 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioROSA Technologies Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Melmed Center, Vanderbilt University
- Responsible party
- Sponsor
- Investigators
- Raun Melmed, MD, Principal investigator, Melmed Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672967
- Sponsor's protocol ID
- 1320036
- Acronym
- MAP
- Status last verified
- Nov 2021
- First submitted
- 11 Dec 2020
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arici H, Causey M, Patra S, Kruger U, Villegas Uribe CA, Melmed R, Ciuk C, Crisler S, Marler S, Witters-Cundiff A, Bhadresa S, Slattery J, Hahn J. Translational Study of Using FOCM/TS Metabolites for Supporting Autism Spectrum Disorder Diagnosis. Ann Biomed Eng. 2026 Sep 3. doi: 10.1007/s10439-026-04365-6. Online ahead of print.
PubMed 42693303
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Autism Prediction (MAP) Study
- ClinicalTrials.gov ID
- NCT04672967
- Acronym / sponsor ID
- MAP / 1320036
- Conditions
- Autism Spectrum Disorder, Developmental Delay
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- BioROSA Technologies IncIndustry (pharma, biotech, devices)
- Collaborators
- Melmed Center, Vanderbilt University
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 17 Dec 2020 (actual)
- 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 pilot clinical trial tests the hypothesis that certain blood metabolite levels can be used to predict Autism Spectrum Disorder (ASD). The study cohort will consist of 200 participants between the ages 18 and 60 months who have been referred to a developmental pediatric center for clinical evaluation of ASD or other developmental delay. Two selected sites will enroll 75 participants each with another 50 typically developing participants. Participants will receive a physical exam (including a dysmorphology evaluation), ADOS, VABS, MSEL, DSM-5, and M-CHAT assessments, and receive a diagnosis. A fasting blood draw is required, consisting of 2 mL vacutainer tubes (max 4 mL). Sites must process blood according to sponsor requirements (outlined in the Sponsor's Laboratory Manual). Certain metabolite levels in the blood will be used for diagnostic screening test development.
Detailed description
The primary objective is to conduct a double-blind, proof-of-concept, two-site, prospective study of 200 children aged 18-60 months that have been referred for an ASD evaluation by a physician to assess the feasibility of a blood test that measures a set of blood plasma metabolites and the classification algorithm developed thereof to predict the risk of ASD.
The secondary objective is to collect additional information for sub-classification of participant cohorts including Vineland Adaptive Behavior Scale (VABS) and Mullen Scale of Early Learning (MSEL) as well as any comorbidities that may correlate with blood test scores.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autism Spectrum Disorder | – | Diagnostic Test: BioROSA MAP testChildren diagnosed with ASD between the ages of 18-60 months |
| Non-ASD (developmental delay or typically developing) | – | Diagnostic Test: BioROSA MAP testChildren diagnosed with non-ASD between the ages of 18-60 months |
Who may qualify
- Ages
- 18 to 60 months
- Sex
- All
- Age groups
- Child
- Study population
- Up to 250 participants, ages 18-60 months suspected of ASD or a developmental delay who are referred for evaluation at participating pediatric developmental centers.
Key inclusion criteria (7 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- 18-60 months of age
- Primary language is English (this is due to the evaluation instruments being used, which are in the English language).
- Suspected developmental concern and referral to the developmental center by child's physician
- Parental informed consent to participate in the study (based on the age range of the children in this study, assent is being waived)
Key exclusion criteria (14 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Previous diagnosis of ASD or DD
- Prematurity < 34 weeks' gestation
- Has a sibling already enrolled in the trial
- Profound sensory deficits (e.g., hearing and vision deficits) that could interfere with the interpretation of study results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioROSA MAP testThe BioROSA MAP test is a blood test that is being developed to predict ASD risk | Diagnostic test | Autism Spectrum Disorder, Non-ASD (developmental delay or typically developing) |
Primary outcome
Autism Diagnostic Observation Scale (ADOS)
Time frame: 1 day (At study entry (one time evaluation))
The Autism Diagnostic Observation Schedule (ADOS) is considered a gold-standard instrument for diagnosing and assessing autism with good diagnostic sensitivity and specificity in young children (37). The ADOS consists of a series of structured and semi-structured tasks that involve social interaction between the examiner and the person under assessment. The examiner observes and identifies segments of the subject's behavior and assigns these to predetermined observational categories. Categorized observations are subsequently combined to produce quantitative scores for analysis and diagnostic classification of ASD. Children at or above predetermined cutoff lines are considered to be positive for ASD.
3 secondary outcomes
Vineland Adaptive Behavior Scale (VABS)
Time frame: 1 day (At study entry (one time evaluation))
Mullen Scales of Early Learning (MSEL)
Time frame: 1 day (At study entry (one time evaluation))
Modified Checklist for Autism in Toddlers (M-CHAT)
Time frame: 1 day (At study entry (one time evaluation))
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Derived from this study: PubMed 42693303Arici H, Causey M, Patra S, Kruger U, Villegas Uribe CA, Melmed R, Ciuk C, Crisler S, Marler S, Witters-Cundiff A, Bhadresa S, Slattery J, Hahn J. Translational Study of Using FOCM/TS Metabolites for Supporting Autism Spectrum Disorder Diagnosis. Ann Biomed Eng. 2026 Sep 3. doi: 10.1007/s10439-026-04365-6. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Raun Melmed, MD principal investigator
Melmed Center
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 Developmental Delay, run by BioROSA Technologies Inc 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 7 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 10 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Craig Ciuk ((480) 443-0050 ext. 324, craig.ciuk@melmedcenter.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autism Diagnostic Observation Scale (ADOS) (time frame: 1 day (At study entry (one time evaluation))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04672967, which also lists 1 linked publication.
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 10 Nov 2021.