ASDNCT07400484
Differences in N-CAD Concentration and Brain Function Between Children With ASD and TD
An observational study of ASD, run by Chen Li at 1 site in China.
Trial summary
The incidence of autism spectrum disorders is increasing, about 1 / 36. Neural cadherin (NCAD) is closely related to synaptic structure and function. The cdh2 gene encoding NCAD has been shown to be associated with a variety of neurodevelopmental diseases and is one of the six risk genes for ASD. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- ASD
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2025to 31 Mar 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: ASD
Who may be able to join
- Age at enrollment ≥ 3 years and <5 years;
- The diagnosis was made by 2 developmental behavioral pediatricians or child psychiatrists with vice senior titles or above, and the history and clinical manifestations were in line with ASD and ICD-11 diagnostic criteria for ASD; .
Who cannot join
- Diagnosis or manifestation of genetic diseases or syndromes related to ASD (such as Rett syndrome);
- Medical or nervous system diseases affecting growth, development or cognition (such as central nervous system infection, epilepsy, congenital heart disease, etc.);
- Sensory impairment such as vision or hearing loss;
- Low birth weight (birth weight <2000 g) or preterm birth (gestational age <37 weeks);
- Adopted children;
- Parents refused to sign the informed consent form;
- Other researchers consider it inappropriate to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Growth, Development and Mental health of Children and Adolescence Center
Chongqing, Chongqing Municipality, 400014
Li Chen, doctor, (+86)136 7762 0103 ext. +86, chenli2012@126.com
About this study
Official title: A Study on the Differences in N-CAD Concentration and Brain Function Between Children With Autism Spectrum Disorder and Typically Developing Children
The incidence of autism spectrum disorders is increasing, about 1 / 36. Neural cadherin (NCAD) is closely related to synaptic structure and function. The cdh2 gene encoding NCAD has been shown to be associated with a variety of neurodevelopmental diseases and is one of the six risk genes for ASD. Functional near-infrared spectroscopy (fNIRS) is a neuroimaging technology that uses the principle of near-infrared spectroscopy to detect the functional activation of human cortex. The application of fNIRS to explore the neural mechanism of children with ASD has developed rapidly. It has the advantages of non-invasive, portable, relatively low cost and unlimited physical activity. And for ASD children, their command compliance and self-control are relatively low, so fNIRS is more widely used in ASD children. According to dsm-5 standard, we recruited ASD children and TD children, collected their peripheral blood, and detected the plasma n-cad concentration. At the same time, the resting state of fNIRS of the two groups of children was collected, and the ultra scan monitoring was carried out simultaneously during Gesell assessment. The purpose of this study was to explore the difference of peripheral blood NCAD concentration between preschool ASD children and TD children and the difference of brain function in resting state and social interaction state. And the relationship between the characteristics of brain function and the level of cognitive development in children with ASD.
Read the detailed description
- Procedure. Children in ASD group and TD group will complete free physical measurement, blood routine and serum nutrient tests, neuropsychological assessment, and near-infrared brain functional imaging after signing up and giving informed consent. 3ml of peripheral blood was collected from the subjects, and the plasma was rapidly separated and frozen in a -80 ℃ refrigerator. The resting state of ASD and TD children was collected using fNIRS, and the ultra scan monitoring was performed simultaneously during Gesell assessment
- Demographic questionnaires and clinical data. The demographic questionnaire was completed by the child's primary caregiver, specifying the child's name, sex, and date of birth. Clinical data will be determined from medical records, including relevant dsm-5 diagnosis, disease classification, etc. The
- Sample size. The sample size was calculated by g*power 3.1. The paired t-test was used to set the effect size d=0.35, α =0.05 (two-sided) Power=0.9， Software calculation showed that 44 cases were needed in each group. Considering the group variability of children and the 10% dropout rate, 49 cases in each group (49 cases in ASD group and 49 cases in TD group) were finally included.
- Statistical analysis. ① NCAD: the R language 4.5.1 statistical software is used for data analysis. The measurement data conforming to the normal distribution adopts the mean ± standard deviation, and the paired sample t test is used for comparison between groups; The median (quartile) was used for non normally distributed measurement data, and Wilcoxon signed rank test was used for comparison between groups. ② Near infrared: nirspark software was used for data preprocessing, R language 4.5.1 statistical software was used for data analysis, Pearson correlation was used for correlation between channels, and generalized linear model (GLM) or mixed effects model was used for comparison between groups. Multiple linear regression model (adjusting for covariates such as age and gender) was used to explore the association between brain activation and DQ level in children with ASD.
- ethical issues and data protection. Patients participating in the study will sign an informed consent form. This study was approved by the local ethics committee. . Parents' authorization of patients' health information remained valid until the study was completed. After that, the researcher will delete the private information from the research record.
- Conditions
- ASD
- Keywords
- ASD, Neural cadherin, Functional Near-infrared Spectroscopy
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 | 1. Age at enrollment ≥ 3 years and <5 years; 2. The diagnosis was made by 2 developmental behavioral pediatricians or child psychiatrists with vice senior titles or above, and the history and clinical manifestations were in line with ASD and ICD-11 diagnostic criteria for ASD. | |
| TD | Match children with ASD based on age and gender, with normal developmental levels (Gesell DQ ≥ 85). |
What is being measured
The primary outcome is the main question the study is designed to answer.
N-CAD
NCAD concentration in peripheral blood: N-cadherin (NCAD) in peripheral blood is a calcium dependent cell adhesion molecule, which is mainly involved in cell-cell recognition and adhesion, and is commonly found in nerve tissue, muscle and vascular endothelium. In peripheral blood, the content is very low under normal conditions, but if N-cadherin is detected to be increased, it may be related to tumor metastasis (such as breast cancer, prostate cancer and other epithelial mesenchymal transition), vascular endothelial injury or some neurological diseases. It can be used as a potential biological marker of tumor invasion or vascular abnormalities, but its detection needs to be combined with other indicators to improve the accuracy.
Measured: Baseline
fNIRS
FNIRS (resting state + superscan): functional near infrared spectroscopy (fNIRS) is a noninvasive brain imaging method that detects hemodynamic changes in the cerebral cortex (such as oxygenated hemoglobin and deoxyhemoglobin concentrations) through near-infrared light, thereby indirectly reflecting neural activity. Resting state fNIRS is used to study the spontaneous activity of the brain in the task-free state, and is often used to explore brain functional networks, disease markers (such as mental disorders or neurodegenerative diseases) and individual differences. While fNIRS hyperscanning synchronously records the brain activity of multiple subjects (such as two people interacting), which is used to study the inter brain synchronization in social cognition, cooperation or competition, and reveal the interpersonal neural mechanism. The combination of the two can expand the understanding of brain resting function and social interaction, and is suitable for psychology, neuroscience a
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start18 Dec 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ASDStudies 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
- 98 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Chen Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chen Li, Children's Hospital of Chongqing Medical University
- Investigators
- Li Chen, doctor, Study chair, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400484
- Sponsor's protocol ID
- DNCBFBCASDTDC
- Status last verified
- Feb 2026
- First submitted
- 25 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is confidential during the study.
Publications
Harrison OJ, Jin X, Hong S, Bahna F, Ahlsen G, Brasch J, Wu Y, Vendome J, Felsovalyi K, Hampton CM, Troyanovsky RB, Ben-Shaul A, Frank J, Troyanovsky SM, Shapiro L, Honig B. The extracellular architecture of adherens junctions revealed by crystal structures of type I cadherins. Structure. 2011 Feb 9;19(2):244-56. doi: 10.1016/j.str.2010.11.016.
PubMed 21300292Jobsis FF. Noninvasive, infrared monitoring of cerebral and myocardial oxygen sufficiency and circulatory parameters. Science. 1977 Dec 23;198(4323):1264-7. doi: 10.1126/science.929199.
PubMed 929199Ferrari M, Quaresima V. A brief review on the history of human functional near-infrared spectroscopy (fNIRS) development and fields of application. Neuroimage. 2012 Nov 1;63(2):921-35. doi: 10.1016/j.neuroimage.2012.03.049. Epub 2012 Mar 28.
PubMed 22510258Liu D, Cao H, Kural KC, Fang Q, Zhang F. Integrative analysis of shared genetic pathogenesis by autism spectrum disorder and obsessive-compulsive disorder. Biosci Rep. 2019 Dec 20;39(12):BSR20191942. doi: 10.1042/BSR20191942.
PubMed 31808517Christensen DL, Baio J, Van Naarden Braun K, Bilder D, Charles J, Constantino JN, Daniels J, Durkin MS, Fitzgerald RT, Kurzius-Spencer M, Lee LC, Pettygrove S, Robinson C, Schulz E, Wells C, Wingate MS, Zahorodny W, Yeargin-Allsopp M; Centers for Disease Control and Prevention (CDC). Prevalence and Characteristics of Autism Spectrum Disorder Among Children Aged 8 Years--Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2012. MMWR Surveill Summ. 2016 Apr 1;65(3):1-23. doi: 10.15585/mmwr.ss6503a1.
PubMed 27031587
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Differences in N-CAD Concentration and Brain Function Between Children With Autism Spectrum Disorder and Typically Developing Children
- ClinicalTrials.gov ID
- NCT07400484
- Acronym / sponsor ID
- DNCBFBCASDTDC
- Conditions
- ASD
- Keywords
- ASD, Neural cadherin, Functional Near-infrared Spectroscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Chen LiUniversity, hospital or other
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 10 Feb 2026 (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.
The incidence of autism spectrum disorders is increasing, about 1 / 36. Neural cadherin (NCAD) is closely related to synaptic structure and function. The cdh2 gene encoding NCAD has been shown to be associated with a variety of neurodevelopmental diseases and is one of the six risk genes for ASD. Functional near-infrared spectroscopy (fNIRS) is a neuroimaging technology that uses the principle of near-infrared spectroscopy to detect the functional activation of human cortex. The application of fNIRS to explore the neural mechanism of children with ASD has developed rapidly. It has the advantages of non-invasive, portable, relatively low cost and unlimited physical activity. And for ASD children, their command compliance and self-control are relatively low, so fNIRS is more widely used in ASD children. According to dsm-5 standard, we recruited ASD children and TD children, collected their peripheral blood, and detected the plasma n-cad concentration. At the same time, the resting state of fNIRS of the two groups of children was collected, and the ultra scan monitoring was carried out simultaneously during Gesell assessment. The purpose of this study was to explore the difference of peripheral blood NCAD concentration between preschool ASD children and TD children and the difference of brain function in resting state and social interaction state. And the relationship between the characteristics of brain function and the level of cognitive development in children with ASD.
Detailed description
- Procedure. Children in ASD group and TD group will complete free physical measurement, blood routine and serum nutrient tests, neuropsychological assessment, and near-infrared brain functional imaging after signing up and giving informed consent. 3ml of peripheral blood was collected from the subjects, and the plasma was rapidly separated and frozen in a -80 ℃ refrigerator. The resting state of ASD and TD children was collected using fNIRS, and the ultra scan monitoring was performed simultaneously during Gesell assessment
- Demographic questionnaires and clinical data. The demographic questionnaire was completed by the child's primary caregiver, specifying the child's name, sex, and date of birth. Clinical data will be determined from medical records, including relevant dsm-5 diagnosis, disease classification, etc. The
- Sample size. The sample size was calculated by g*power 3.1. The paired t-test was used to set the effect size d=0.35, α =0.05 (two-sided) Power=0.9， Software calculation showed that 44 cases were needed in each group. Considering the group variability of children and the 10% dropout rate, 49 cases in each group (49 cases in ASD group and 49 cases in TD group) were finally included.
- Statistical analysis. ① NCAD: the R language 4.5.1 statistical software is used for data analysis. The measurement data conforming to the normal distribution adopts the mean ± standard deviation, and the paired sample t test is used for comparison between groups; The median (quartile) was used for non normally distributed measurement data, and Wilcoxon signed rank test was used for comparison between groups. ② Near infrared: nirspark software was used for data preprocessing, R language 4.5.1 statistical software was used for data analysis, Pearson correlation was used for correlation between channels, and generalized linear model (GLM) or mixed effects model was used for comparison between groups. Multiple linear regression model (adjusting for covariates such as age and gender) was used to explore the association between brain activation and DQ level in children with ASD.
- ethical issues and data protection. Patients participating in the study will sign an informed consent form. This study was approved by the local ethics committee. . Parents' authorization of patients' health information remained valid until the study was completed. After that, the researcher will delete the private information from the research record.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD | – | –1. Age at enrollment ≥ 3 years and <5 years; 2. The diagnosis was made by 2 developmental behavioral pediatricians or child psychiatrists with vice senior titles or above, and the history and clinical manifestations were in line with ASD and ICD-11 diagnostic criteria for ASD. |
| TD | – | –Match children with ASD based on age and gender, with normal developmental levels (Gesell DQ ≥ 85). |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- ASD
Key inclusion criteria (2 listed)
- Age at enrollment ≥ 3 years and <5 years;
- The diagnosis was made by 2 developmental behavioral pediatricians or child psychiatrists with vice senior titles or above, and the history and clinical manifestations were in line with ASD and ICD-11 diagnostic criteria for ASD; .
Key exclusion criteria (7 listed)
- Diagnosis or manifestation of genetic diseases or syndromes related to ASD (such as Rett syndrome);
- Medical or nervous system diseases affecting growth, development or cognition (such as central nervous system infection, epilepsy, congenital heart disease, etc.);
- Sensory impairment such as vision or hearing loss;
- Low birth weight (birth weight <2000 g) or preterm birth (gestational age <37 weeks);
- Adopted children;
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
N-CAD
Time frame: Baseline
NCAD concentration in peripheral blood: N-cadherin (NCAD) in peripheral blood is a calcium dependent cell adhesion molecule, which is mainly involved in cell-cell recognition and adhesion, and is commonly found in nerve tissue, muscle and vascular endothelium. In peripheral blood, the content is very low under normal conditions, but if N-cadherin is detected to be increased, it may be related to tumor metastasis (such as breast cancer, prostate cancer and other epithelial mesenchymal transition), vascular endothelial injury or some neurological diseases. It can be used as a potential biological marker of tumor invasion or vascular abnormalities, but its detection needs to be combined with other indicators to improve the accuracy.
fNIRS
Time frame: Baseline
FNIRS (resting state + superscan): functional near infrared spectroscopy (fNIRS) is a noninvasive brain imaging method that detects hemodynamic changes in the cerebral cortex (such as oxygenated hemoglobin and deoxyhemoglobin concentrations) through near-infrared light, thereby indirectly reflecting neural activity. Resting state fNIRS is used to study the spontaneous activity of the brain in the task-free state, and is often used to explore brain functional networks, disease markers (such as mental disorders or neurodegenerative diseases) and individual differences. While fNIRS hyperscanning synchronously records the brain activity of multiple subjects (such as two people interacting), which is used to study the inter brain synchronization in social cognition, cooperation or competition, and reveal the interpersonal neural mechanism. The combination of the two can expand the understanding of brain resting function and social interaction, and is suitable for psychology, neuroscience a
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Results publication: PubMed 21300292Harrison OJ, Jin X, Hong S, Bahna F, Ahlsen G, Brasch J, Wu Y, Vendome J, Felsovalyi K, Hampton CM, Troyanovsky RB, Ben-Shaul A, Frank J, Troyanovsky SM, Shapiro L, Honig B. The extracellular architecture of adherens junctions revealed by crystal structures of type I cadherins. Structure. 2011 Feb 9;19(2):244-56. doi: 10.1016/j.str.2010.11.016.
- Results publication: PubMed 929199Jobsis FF. Noninvasive, infrared monitoring of cerebral and myocardial oxygen sufficiency and circulatory parameters. Science. 1977 Dec 23;198(4323):1264-7. doi: 10.1126/science.929199.
- Results publication: PubMed 22510258Ferrari M, Quaresima V. A brief review on the history of human functional near-infrared spectroscopy (fNIRS) development and fields of application. Neuroimage. 2012 Nov 1;63(2):921-35. doi: 10.1016/j.neuroimage.2012.03.049. Epub 2012 Mar 28.
- Results publication: PubMed 31808517Liu D, Cao H, Kural KC, Fang Q, Zhang F. Integrative analysis of shared genetic pathogenesis by autism spectrum disorder and obsessive-compulsive disorder. Biosci Rep. 2019 Dec 20;39(12):BSR20191942. doi: 10.1042/BSR20191942.
- Results publication: PubMed 27031587Christensen DL, Baio J, Van Naarden Braun K, Bilder D, Charles J, Constantino JN, Daniels J, Durkin MS, Fitzgerald RT, Kurzius-Spencer M, Lee LC, Pettygrove S, Robinson C, Schulz E, Wells C, Wingate MS, Zahorodny W, Yeargin-Allsopp M; Centers for Disease Control and Prevention (CDC). Prevalence and Characteristics of Autism Spectrum Disorder Among Children Aged 8 Years--Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2012. MMWR Surveill Summ. 2016 Apr 1;65(3):1-23. doi: 10.15585/mmwr.ss6503a1.
- Individual participant dataSharing planned: No. Data is confidential during the study.
Related trials for ASD
Recruiting
Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD
Autism Spectrum Disorder, Therapy
Recruiting
Smith Magenis Syndrome and Autism Spectrum Disorders
Smith-Magenis Syndrome, Autism Spectrum Disorder
Active, not recruitingPhase 1
Psilocybin for Treatment-Resistant Depression in Autism
Treatment Resistant Depression, Autism Spectrum Disorder
RecruitingPhase 2
TRIal of PPF3 vs. PlaCEbo in the TReatment of Children and AdolescenTs With NeurOdeveloPmental DisorderS
Autism Disorder
Not yet recruitingObservational study
EEG As a Genetic Selection Lever in Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
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.
Li Chen, doctor study chair
Children's Hospital of Chongqing Medical University
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 ASD, run by Chen Li at 1 site in China.
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 7 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: looking for participants now, as of the sponsor's last update on 10 Feb 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Chen, doctor (13677620103 ext. +86, chenli2012@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
N-CAD (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT07400484, which also lists 5 linked publications.
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 Feb 2026.