Ignite Creation Date:
2024-05-06 @ 7:31 AM
Last Modification Date:
2024-10-26 @ 11:49 AM
Study NCT ID:
NCT02548442
Status:
UNKNOWN
Last Update Posted:
2020-06-29
First Post:
2015-09-02
Brief Title:
Childrens Autism Metabolome Project
Sponsor:
Stemina Biomarker Discovery Inc
Organization:
Stemina Biomarker Discovery Inc
Study Overview
Official Title:
Childrens Autism Metabolome Project CAMP Development and Clinical Evaluation of the Stemina Metabolic Biomarker-Based Test to Diagnose Autism Spectrum Disorder in Early Childhood
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAMP-01
Brief Summary:
Development and Clinical Evaluation of the Stemina Metabolic Biomarker-Based Test to Diagnose Autism Spectrum Disorder in Early Childhood
Detailed Description:
The purpose of this study is to identify metabolitic signatures in blood plasma andor urine using a panel of biomarker metabolites that differentiate children with autism spectrum disorder ASD from children with delayed development DD andor typical development TD to develop an algorithm that maximizes sensitivity and specificity of the biomarker profile and to evaluate the overall algorithm as a diagnostic tool
A secondary objective is to define metabolites capable of classifying subtypes of ASD that may increase understanding of the metabolic basis of the condition as well as inform on personalized therapy
The population targeted for this study includes children aged 18 months to 48 months diagnosed with ASD or DD using behavioral criteria and TD children identified as having no indications of ASD or DD using behavioral criteria The original target size for the study was 1500 subjects divided equally between the three groups The targeted malefemale ratio is 41 in all three groups During the study it was determined that biomarkers capable of identifying ASD subjects could be obtained using a total of 1100 subjects divided with 58 ASD 25TD and 17 DD If the diagnostic biomarkers identified in the study do not perform well in females during the biomarker discovery phase the study may be expanded to recruit more females to examine the possibility of a female-specific diagnostic test
Subjects will be qualified for entry into the study and will be invited to participate On the first study day subjects parents will sign an informed consent form and will be asked questions on the mothers pregnancy and of both parents medical history A complete medical history a physical examination and information needed to obtain a diagnosis of ASD DD or TD will be obtained on the study subject If possible a urine sample will be collected during the visit Up to four tubes of blood 25 mLs total will be drawn at the clinic during the visit or within 14 days following this initial visit An overnight fast is required prior to the visit where blood will be taken from the subject A subset of the subjects will be asked to return to the clinic 30-60 days later to obtain a replicate metabolic profile
The study will be divided into a biomarker discoverymethod development phase followed by a validation phase of the analytical methods and algorithm that will be used in the clinical test
The subjects will be randomized and divided equally between a discoverytraining set and a validation set The training set will be used for discovery of the biomarkers and development of the analytical methods intended for the diagnostic test The validation sample set will be used to evaluate performance of the final clinical methods and algorithms
Consent will also be sought from all subjects for follow-up contact up to 5 years following enrollment of the last subject enrolled to determine the accuracy of the original behavioral diagnosis over time Subjects chosen for follow-up will be identified based on the strength of the diagnosis from the behavioral scores and physician assessments as well as the biomarker profiles observed in individuals
A secondary objective is to define metabolites capable of classifying subtypes of ASD that may increase understanding of the metabolic basis of the condition as well as inform on personalized therapy
The population targeted for this study includes children aged 18 months to 48 months diagnosed with ASD or DD using behavioral criteria and TD children identified as having no indications of ASD or DD using behavioral criteria The original target size for the study was 1500 subjects divided equally between the three groups The targeted malefemale ratio is 41 in all three groups During the study it was determined that biomarkers capable of identifying ASD subjects could be obtained using a total of 1100 subjects divided with 58 ASD 25TD and 17 DD If the diagnostic biomarkers identified in the study do not perform well in females during the biomarker discovery phase the study may be expanded to recruit more females to examine the possibility of a female-specific diagnostic test
Subjects will be qualified for entry into the study and will be invited to participate On the first study day subjects parents will sign an informed consent form and will be asked questions on the mothers pregnancy and of both parents medical history A complete medical history a physical examination and information needed to obtain a diagnosis of ASD DD or TD will be obtained on the study subject If possible a urine sample will be collected during the visit Up to four tubes of blood 25 mLs total will be drawn at the clinic during the visit or within 14 days following this initial visit An overnight fast is required prior to the visit where blood will be taken from the subject A subset of the subjects will be asked to return to the clinic 30-60 days later to obtain a replicate metabolic profile
The study will be divided into a biomarker discoverymethod development phase followed by a validation phase of the analytical methods and algorithm that will be used in the clinical test
The subjects will be randomized and divided equally between a discoverytraining set and a validation set The training set will be used for discovery of the biomarkers and development of the analytical methods intended for the diagnostic test The validation sample set will be used to evaluate performance of the final clinical methods and algorithms
Consent will also be sought from all subjects for follow-up contact up to 5 years following enrollment of the last subject enrolled to determine the accuracy of the original behavioral diagnosis over time Subjects chosen for follow-up will be identified based on the strength of the diagnosis from the behavioral scores and physician assessments as well as the biomarker profiles observed in individuals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R44MH107124-01 | NIH | None | httpsreporternihgovquickSearchR44MH107124-01 |