Gene Product Sequence VariationNCT03018574
Candidate Gene Screening for Attention Deficit/Hyperactive Disorder (ADHD)
An observational study of Gene Product Sequence Variation, run by Xijing Hospital at 1 site in China.
Trial summary
Source: Sample bank of Xijing Hospital and Children's Hospital Affiliated to Soochow University; Sample form: Whole blood; Estimated number of samples: 100 patients with ADHD and age, sex matched healthy controls; Case exclusion criteria: all kinds of neuropsychiatric disorders, IQ value of less than 70; Study… Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Gene Product Sequence Variation
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Jan 2017
- 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 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Diagnoses of the children with ADHD were made in Xijing Hospital and Children's Hospital Affiliated to Soochow University according to criteria described in the Diagnostic and Statistical Manual of Mental Disorders. Children with ADHD had an IQ score above 70.
Who may be able to join
- Diagnoses of the children with ADHD were made in Xijing Hospital and Children's Hospital Affiliated to Soochow University according to criteria described in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). Children with ADHD had an IQ score above 70.
Who cannot join
- Children who had a past history of or were currently affected by neurological diseases, including convulsive disorders or brain damage; or who had any evidence of comorbid psychiatric conditions, such as Tourette's syndrome, IQ below 70, pervasive developmental disorder (autism), bipolar disorder, psychosis, language difficulties or learning disorders (reading disorders, mathematics disorders and disorders of written expression).
Trial locations and contacts
1 site in 1 country.
China1 site
Xijing Hospital of the Fourth Military Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: Candidate Gene Screening for 6-14 Year Old Patients With ADHD (Attention Deficit/ Hyperactivity Disorder)
Source: Sample bank of Xijing Hospital and Children's Hospital Affiliated to Soochow University; Sample form: Whole blood; Estimated number of samples: 100 patients with ADHD and age, sex matched healthy controls; Case exclusion criteria: all kinds of neuropsychiatric disorders, IQ value of less than 70;
Study protocol:
- Using Qiagen kit to extract the genomic DNA of 200 microliters of blood.
- UV spectrophotometer test DNA purity of 260/280 close to 1.8 (1.8 ± 0.05), the concentration of 100ng/μL or more before the next sequencing.
- The extracted genomic DNA will be sent to Sangon Biology Engineering Limited Company (Shanghai) and sequenced to find candidate mutations related to ADHD risk sequence. According to NIH gene database, the longest transcript of NDRG2 (ID: 57447 gene, https://www.ncbi.nlm.nih.gov/nuccore/NC_000014.9? Report=genbank\&from=21016763\&to=21070872\&strand=true) (a total of 17 exons and 16 introns and the gene 5 'UTR and 3' UTR region) will be alignmented sequences to find potential mutations.
- Using the chi square analysis and other statistical methods to determine the relationship between the mutations and susceptibility to ADHD.
Read the detailed description
Source: Sample bank of Xijing Hospital and Children's Hospital Affiliated to Soochow University; Sample form: Whole blood; Estimated number of samples: 100 patients with ADHD and age, sex matched healthy controls; Case exclusion criteria: all kinds of neuropsychiatric disorders, IQ value of less than 70;
Study protocol:
- Using Qiagen kit to extract the genomic DNA of 200 microliters of blood. (1) melt frozen blood at room temperature; (2) take the blood of 0.2 ml into a sterile anti coagulation centrifuge tube, add an equal volume of PBS phosphate buffer, after fully mixing 12000rpm centrifugation 5min, discard supernatant; (3) 66.7 L STE 2.4 L, 20% SDS, 37 DEG C water bath 1h; (4) protease K plus 1 20mg/ml l mix, 55 DEG C water bath digestion overnight (10 ~ 14h); (5) the digested samples treated with Tris saturated phenol, shake well, 12000rpm centrifugal 10min; (6) the upper aqueous phase to a sterile centrifuge tube; adding volume of Tris saturated phenol, shake well, 12000rpm centrifugal 10min; (7) the upper aqueous phase was transferred to another sterile centrifuge tube, and an equal volume of phenol was added: chloroform: isoamyl alcohol (25: 24: 1). The oscillation of the vortex was fully mixed, and the 12000rpm was centrifuged to 10min; (8) the upper aqueous phase was transferred to another sterile centrifuge tube, and an equal volume of chloroform was added: iso amyl alcohol (24: 1), which was fully vibrated and mixed with 12000rpm centrifugation 10min; (9) transfer the supernatant to another sterile centrifuge tube; adding 2 times volume ethanol, the volume level of sodium acetate 1/10 shake, until the flocculent precipitation of DNA visible; (10) the sample is placed at -20 DEG C refrigerator freezer 30min or ice bath for 15 ~ 20min, after removal of 12000rpm centrifugal 10min again, so that DNA precipitation; (11) the gun head will pick DNA to another sterile centrifugal tube, with the amount of 70% ethanol washing and shaking, to wash out impurities DNA; (12) out of ethanol, DNA by vacuum drying or dry naturally, TE buffer adding dissolution, -20 stored at standby.
- UV spectrophotometer test DNA purity of 260/280 close to 1.8 (1.8 ± 0.05), the concentration of 100ng/μL or more before the next sequencing.
- The extracted genomic DNA will be sent to Sangon Biology Engineering Limited Company (Shanghai) and sequenced to find candidate mutations related to ADHD risk sequence. According to NIH gene database, the longest transcript of NDRG2 (ID: 57447 gene, https://www.ncbi.nlm.nih.gov/nuccore/NC_000014.9? Report=genbank\&from=21016763\&to=21070872\&strand=true) (a total of 17 exons and 16 introns and the gene 5 'UTR and 3' UTR region) will be alignmented sequences to find potential mutations.
- Using the chi square analysis and other statistical methods to determine the relationship between the mutations and susceptibility to ADHD.
- Conditions
- Gene Product Sequence Variation
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 |
|---|---|---|
| ADHD-patients | The whole blood sample from diagnoses of the children 6-14 years old with ADHD. Diagnoses of the children with ADHD were made in Xijing Hospital and Children's Hospital Affiliated to Soochow University according to criteria described in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). Children with ADHD had an IQ score above 70. | |
| Controls-healthy children | The whole blood sample from age- and gender- matched healthy 6-14 years old children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene point mutation in the genome of ADHD patients and healthy controls
Measured: 2016-2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startMay 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gene Product Sequence VariationStudies 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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Soochow University
- Responsible party
- Sponsor
- Investigators
- Yan Li, PhD&MD, Principal investigator, Xijing hospital of The fourth military medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018574
- Sponsor's protocol ID
- KY20163381
- Status last verified
- Jan 2017
- First submitted
- 11 Jan 2017
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Publish all data in a paper
Publications
Won H, Mah W, Kim E, Kim JW, Hahm EK, Kim MH, Cho S, Kim J, Jang H, Cho SC, Kim BN, Shin MS, Seo J, Jeong J, Choi SY, Kim D, Kang C, Kim E. GIT1 is associated with ADHD in humans and ADHD-like behaviors in mice. Nat Med. 2011 May;17(5):566-72. doi: 10.1038/nm.2330. Epub 2011 Apr 17.
PubMed 21499268Salatino-Oliveira A, Genro JP, Chazan R, Zeni C, Schmitz M, Polanczyk G, Roman T, Rohde LA, Hutz MH. Association study of GIT1 gene with attention-deficit hyperactivity disorder in Brazilian children and adolescents. Genes Brain Behav. 2012 Oct;11(7):864-8. doi: 10.1111/j.1601-183X.2012.00835.x. Epub 2012 Sep 7.
PubMed 22897819Vegt R, Bertoli-Avella AM, Tulen JH, de Graaf B, Verkerk AJ, Vervoort J, Twigt CM, Maat-Kievit A, van Tuijl R, van der Lijn M, Hengeveld MW, Oostra BA. Genome-wide linkage analysis in a Dutch multigenerational family with attention deficit hyperactivity disorder. Eur J Hum Genet. 2010 Feb;18(2):206-11. doi: 10.1038/ejhg.2009.148. Epub 2009 Aug 26.
PubMed 19707245
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Candidate Gene Screening for 6-14 Year Old Patients With ADHD (Attention Deficit/ Hyperactivity Disorder)
- ClinicalTrials.gov ID
- NCT03018574
- Acronym / sponsor ID
- KY20163381
- Conditions
- Gene Product Sequence Variation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Soochow University
- Study start
- May 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 12 Jan 2017 (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.
Source: Sample bank of Xijing Hospital and Children's Hospital Affiliated to Soochow University; Sample form: Whole blood; Estimated number of samples: 100 patients with ADHD and age, sex matched healthy controls; Case exclusion criteria: all kinds of neuropsychiatric disorders, IQ value of less than 70;
Study protocol:
- Using Qiagen kit to extract the genomic DNA of 200 microliters of blood.
- UV spectrophotometer test DNA purity of 260/280 close to 1.8 (1.8 ± 0.05), the concentration of 100ng/μL or more before the next sequencing.
- The extracted genomic DNA will be sent to Sangon Biology Engineering Limited Company (Shanghai) and sequenced to find candidate mutations related to ADHD risk sequence. According to NIH gene database, the longest transcript of NDRG2 (ID: 57447 gene, https://www.ncbi.nlm.nih.gov/nuccore/NC_000014.9? Report=genbank\&from=21016763\&to=21070872\&strand=true) (a total of 17 exons and 16 introns and the gene 5 'UTR and 3' UTR region) will be alignmented sequences to find potential mutations.
- Using the chi square analysis and other statistical methods to determine the relationship between the mutations and susceptibility to ADHD.
Detailed description
Source: Sample bank of Xijing Hospital and Children's Hospital Affiliated to Soochow University; Sample form: Whole blood; Estimated number of samples: 100 patients with ADHD and age, sex matched healthy controls; Case exclusion criteria: all kinds of neuropsychiatric disorders, IQ value of less than 70;
Study protocol:
- Using Qiagen kit to extract the genomic DNA of 200 microliters of blood. (1) melt frozen blood at room temperature; (2) take the blood of 0.2 ml into a sterile anti coagulation centrifuge tube, add an equal volume of PBS phosphate buffer, after fully mixing 12000rpm centrifugation 5min, discard supernatant; (3) 66.7 L STE 2.4 L, 20% SDS, 37 DEG C water bath 1h; (4) protease K plus 1 20mg/ml l mix, 55 DEG C water bath digestion overnight (10 ~ 14h); (5) the digested samples treated with Tris saturated phenol, shake well, 12000rpm centrifugal 10min; (6) the upper aqueous phase to a sterile centrifuge tube; adding volume of Tris saturated phenol, shake well, 12000rpm centrifugal 10min; (7) the upper aqueous phase was transferred to another sterile centrifuge tube, and an equal volume of phenol was added: chloroform: isoamyl alcohol (25: 24: 1). The oscillation of the vortex was fully mixed, and the 12000rpm was centrifuged to 10min; (8) the upper aqueous phase was transferred to another sterile centrifuge tube, and an equal volume of chloroform was added: iso amyl alcohol (24: 1), which was fully vibrated and mixed with 12000rpm centrifugation 10min; (9) transfer the supernatant to another sterile centrifuge tube; adding 2 times volume ethanol, the volume level of sodium acetate 1/10 shake, until the flocculent precipitation of DNA visible; (10) the sample is placed at -20 DEG C refrigerator freezer 30min or ice bath for 15 ~ 20min, after removal of 12000rpm centrifugal 10min again, so that DNA precipitation; (11) the gun head will pick DNA to another sterile centrifugal tube, with the amount of 70% ethanol washing and shaking, to wash out impurities DNA; (12) out of ethanol, DNA by vacuum drying or dry naturally, TE buffer adding dissolution, -20 stored at standby.
- UV spectrophotometer test DNA purity of 260/280 close to 1.8 (1.8 ± 0.05), the concentration of 100ng/μL or more before the next sequencing.
- The extracted genomic DNA will be sent to Sangon Biology Engineering Limited Company (Shanghai) and sequenced to find candidate mutations related to ADHD risk sequence. According to NIH gene database, the longest transcript of NDRG2 (ID: 57447 gene, https://www.ncbi.nlm.nih.gov/nuccore/NC_000014.9? Report=genbank\&from=21016763\&to=21070872\&strand=true) (a total of 17 exons and 16 introns and the gene 5 'UTR and 3' UTR region) will be alignmented sequences to find potential mutations.
- Using the chi square analysis and other statistical methods to determine the relationship between the mutations and susceptibility to ADHD.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD-patients | – | –The whole blood sample from diagnoses of the children 6-14 years old with ADHD. Diagnoses of the children with ADHD were made in Xijing Hospital and Children's Hospital Affiliated to Soochow University according to criteria described in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). Children with ADHD had an IQ score above 70. |
| Controls-healthy children | – | –The whole blood sample from age- and gender- matched healthy 6-14 years old children |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Diagnoses of the children with ADHD were made in Xijing Hospital and Children's Hospital Affiliated to Soochow University according to criteria described in the Diagnostic and Statistical Manual of Mental Disorders. Children with ADHD had an IQ score above 70.
Key inclusion criteria (1 listed)
- Diagnoses of the children with ADHD were made in Xijing Hospital and Children's Hospital Affiliated to Soochow University according to criteria described in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). Children with ADHD had an IQ score above 70.
Key exclusion criteria (1 listed)
- Children who had a past history of or were currently affected by neurological diseases, including convulsive disorders or brain damage; or who had any evidence of comorbid psychiatric conditions, such as Tourette's syndrome, IQ below 70, pervasive developmental disorder (autism), bipolar disorder, psychosis, language difficulties or learning disorders (reading disorders, mathematics disorders and disorders of written expression).
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
Gene point mutation in the genome of ADHD patients and healthy controls
Time frame: 2016-2017
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 26 Feb 2018.
- Results publication: PubMed 21499268Won H, Mah W, Kim E, Kim JW, Hahm EK, Kim MH, Cho S, Kim J, Jang H, Cho SC, Kim BN, Shin MS, Seo J, Jeong J, Choi SY, Kim D, Kang C, Kim E. GIT1 is associated with ADHD in humans and ADHD-like behaviors in mice. Nat Med. 2011 May;17(5):566-72. doi: 10.1038/nm.2330. Epub 2011 Apr 17.
- Results publication: PubMed 22897819Salatino-Oliveira A, Genro JP, Chazan R, Zeni C, Schmitz M, Polanczyk G, Roman T, Rohde LA, Hutz MH. Association study of GIT1 gene with attention-deficit hyperactivity disorder in Brazilian children and adolescents. Genes Brain Behav. 2012 Oct;11(7):864-8. doi: 10.1111/j.1601-183X.2012.00835.x. Epub 2012 Sep 7.
- Results publication: PubMed 19707245Vegt R, Bertoli-Avella AM, Tulen JH, de Graaf B, Verkerk AJ, Vervoort J, Twigt CM, Maat-Kievit A, van Tuijl R, van der Lijn M, Hengeveld MW, Oostra BA. Genome-wide linkage analysis in a Dutch multigenerational family with attention deficit hyperactivity disorder. Eur J Hum Genet. 2010 Feb;18(2):206-11. doi: 10.1038/ejhg.2009.148. Epub 2009 Aug 26.
- Individual participant dataSharing planned: Yes. Publish all data in a paper
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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.
Yan Li, PhD&MD principal investigator
Xijing hospital of The fourth military 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 Gene Product Sequence Variation, run by Xijing Hospital 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 1 inclusion and 1 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 26 Feb 2018. 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?
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?
Gene point mutation in the genome of ADHD patients and healthy controls (time frame: 2016-2017). 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 NCT03018574, which also lists 3 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 26 Feb 2018.