Learning DisabilitiesNCT02227381
Action Medical Research
An observational study of Learning Disabilities, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Learning disability affects 3% of the population. Severe types of learning disability are more likely to have an underlying genetic cause but diagnosis is difficult because many different genetic abnormalities may be involved. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Learning Disabilities
- How many people
- 119 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2011to Jun 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We will approach a cohort of patients with severe LD/seizures/behaviour problems who have presented to us in our genetic clinic for diagnosis over the past few years, but where the cause of their problems remains unknown. This will be our study population. In virtually all cases we will have performed routine diagnostic testing and will have stored DNA.
Who may be able to join
- Individuals with severe learning disability associated with either seizures, movement or behaviour problems who had previously undergone routine investigation but where no cause had been identified for their problems
Who cannot join
- Individuals with SLD where the cause is already known
- Individuals where informed consent cannot be obtained for participation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Central Manchester University Hospitals NHS Foundation Trust
Manchester, M13 9WL
About this study
Official title: Using New Genetic Technology to Diagnose Neurodevelopmental Disorders
Learning disability affects 3% of the population. Severe types of learning disability are more likely to have an underlying genetic cause but diagnosis is difficult because many different genetic abnormalities may be involved. Obtaining a diagnosis is important so that patients can be managed appropriately and their families can be given accurate information.
We aim to use new types of genetic testing which will make it possible to screen for several different genetic abnormalities which cause learning disability at the same time, so improving the accuracy and speed of diagnosis in the group of patients with severe learning disability. We will focus particularly on patients where seizures and behavioural problems are also present.This will enable more patients to be diagnosed accurately, reduce the number of hospital appointments needed and ultimately be more cost- effective.
- Conditions
- Learning Disabilities
- Medical subject headings
- 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 |
|---|---|---|
| Microarray / NGS test | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic abnormality identified by microarray or Next Generation Sequencing
Abnormalities identified upon results of testing, the normal timeframe for this is up to 6 months after collecting blood sample.
Measured: up to 6 months following consent
Secondary outcomes (1)
Cost effectiveness vs normal care
This analysis will be performed for all participants following close of recruitment \& follow up, and will be completed by the time the study ends.
Measured: By the end of the study (December 2014)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startFeb 2011
- Primary completionDec 2013
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Learning DisabilitiesStudies 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
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jill Clayton Smith, MB ChB FRCP MD, Principal investigator, CMFT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227381
- Sponsor's protocol ID
- 10/H1003/98
- Other IDs
- SP4555
- Status last verified
- Nov 2018
- First submitted
- 26 Aug 2014
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using New Genetic Technology to Diagnose Neurodevelopmental Disorders
- ClinicalTrials.gov ID
- NCT02227381
- Acronym / sponsor ID
- 10/H1003/98
- Conditions
- Learning Disabilities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- Feb 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 28 Aug 2014 (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.
Learning disability affects 3% of the population. Severe types of learning disability are more likely to have an underlying genetic cause but diagnosis is difficult because many different genetic abnormalities may be involved. Obtaining a diagnosis is important so that patients can be managed appropriately and their families can be given accurate information.
We aim to use new types of genetic testing which will make it possible to screen for several different genetic abnormalities which cause learning disability at the same time, so improving the accuracy and speed of diagnosis in the group of patients with severe learning disability. We will focus particularly on patients where seizures and behavioural problems are also present.This will enable more patients to be diagnosed accurately, reduce the number of hospital appointments needed and ultimately be more cost- effective.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microarray / NGS test | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We will approach a cohort of patients with severe LD/seizures/behaviour problems who have presented to us in our genetic clinic for diagnosis over the past few years, but where the cause of their problems remains unknown. This will be our study population. In virtually all cases we will have performed routine diagnostic testing and will have stored DNA.
Key inclusion criteria (1 listed)
- Individuals with severe learning disability associated with either seizures, movement or behaviour problems who had previously undergone routine investigation but where no cause had been identified for their problems
Key exclusion criteria (2 listed)
- Individuals with SLD where the cause is already known
- Individuals where informed consent cannot be obtained for participation
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
Genetic abnormality identified by microarray or Next Generation Sequencing
Time frame: up to 6 months following consent
Abnormalities identified upon results of testing, the normal timeframe for this is up to 6 months after collecting blood sample.
1 secondary outcome
Cost effectiveness vs normal care
Time frame: By the end of the study (December 2014)
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 4 Dec 2018.
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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.
Jill Clayton Smith, MB ChB FRCP MD principal investigator
CMFT
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 Learning Disabilities, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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 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 4 Dec 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 United Kingdom. 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?
Genetic abnormality identified by microarray or Next Generation Sequencing (time frame: up to 6 months following consent). 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 4 Dec 2018.