Genetic of Intellectual DeficiencyRaDiCo-GenIDANCT06871696
Genetic of Intellectual Deficiency and Autism Spectrum Disorders (RaDiCo-GenIDA)
An observational study of Genetic of Intellectual Deficiency and Autism Spectrum Disorder, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
The aim of this observational study is to develop an alternative database model for genetically originated intellectual disabilities. This model will take the form of an online cohort study, where the majority of clinical information will be provided by the families of the patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genetic of Intellectual Deficiency, Autism Spectrum Disorder
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2016to Nov 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The studied population includes all patients (and their relatives*) affected by intellectual disability (ID) and/or autism spectrum disorders (ASD) of known genetic origin, on an international scale.
Who may be able to join
- Be a voluntary adult (aged 18 or older)
- Be a family member (i.e., mother/father) of patients with intellectual disabilities and/or autism spectrum disorders of known genetic origin. This includes monogenic causes as well as recurrent copy number variations (CNVs) such as deletions or duplications. Note: we also allow adult patients to participate directly if they wish and have the capacity to do so.
- Have knowledge of the genetic cause behind intellectual disabilities or autism spectrum disorders. An exception to this rule is possible for patients with a syndrome that includes intellectual disabilities or autism spectrum disorders, and for whom genetic investigation is considered, with the approval of the project's scientific council (which will define the syndromes eligible for this exception).
- Have the intellectual and material capabilities to complete an internet questionnaire.
- Have read the information sheet regarding the study and agreed to the general conditions of participation in the study.
- There are no restrictions based on age, gender, or potential comorbidities of the individual themselves.
Who cannot join
- Patients affected by the presence of intellectual disability and/or an autism spectrum disorder of unknown genetic origin will not be able to participate in the study, except with the exception mentioned in the previous chapter.
- It is requested that only adults enter data. However, the collected data may pertain to a minor (in the case of a parent entering data about their minor child)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
RaDiCo-GenIDA
Paris, Île-de-France Region, 75012
Sonia Gueguen, PHD, 06 88 34 54 08, sonia.gueguen@radico.fr
Jean-Louis Mandel, Pr
About this study
Official title: Genetic of Intellectual Deficiency and Autism Spectrum Disorders
The aim of this observational study is to develop an alternative database model for genetically originated intellectual disabilities. This model will take the form of an online cohort study, where the majority of clinical information will be provided by the families of the patients. Questionnaires developed by professionals but formulated in a way understandable to families will be used to gather this information.
Specifically, this study aims to collect relevant information for personalized medical management. This includes understanding the risks of specific pathological complications and potential iatrogenic effects of symptomatic treatments. The primary goal is to establish groups of individuals with intellectual disabilities and/or autism spectrum disorders (ASD) sharing the same genetic mutation. This approach will provide a better understanding of the natural history of the disease and associated comorbidities.
Read more
It is important to note that this project will only focus on patients for whom the identification of the causal mutation or penetrant copy number variation (CNV) has been determined. It excludes individuals for whom the cause of intellectual disability is unknown.
This approach will contribute to a better understanding of the genetic aspects of intellectual disabilities and ASD, while facilitating more targeted and personalized medical care for the affected patients.
- Keywords
- Autism Spectrum, Intellectual Disability, Rare disease, Genetic origin
- Medical subject headings
- Autism Spectrum Disorder, Intellectual Disability, Rare Diseases
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 |
|---|---|---|
| Institut National de la Santé et de la Recherche Médicale, France | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the clinical and "para-clinical" characteristics of the disease over time in adult and pediatric patients, depending on the type of genetic anomaly associated with the disease.
Measured: Day 1, Every 6 months over 5 years
Secondary outcomes (3)
Identification of new information regarding the challenges faced by individuals with Intellectual Disability/Autism Spectrum Disorder (ID/ASD), based on their age (pediatric/adult) and type of anomaly (genetic/environmental factor).
Measured: Day 1, Every 6 months over 5 years
Search for associations between certain phenotypic and genotypic/environmental factor characteristics to which individuals have been exposed.
Measured: Day 1, Every 6 months over 5 years
Description of the dynamics of exchanges among families (no access to content, description of the number of participating families, frequency of exchanges, etc.)
Measured: Day 1, Every 6 months over 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study startNov 2016
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic of Intellectual DeficiencyStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871696
- Sponsor's protocol ID
- C14-35
- Acronym
- RaDiCo-GenIDA
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic of Intellectual Deficiency and Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT06871696
- Acronym / sponsor ID
- RaDiCo-GenIDA / C14-35
- Keywords
- Autism Spectrum, Intellectual Disability, Rare disease, Genetic origin
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Nov 2016 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 12 Mar 2025 (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 aim of this observational study is to develop an alternative database model for genetically originated intellectual disabilities. This model will take the form of an online cohort study, where the majority of clinical information will be provided by the families of the patients. Questionnaires developed by professionals but formulated in a way understandable to families will be used to gather this information.
Specifically, this study aims to collect relevant information for personalized medical management. This includes understanding the risks of specific pathological complications and potential iatrogenic effects of symptomatic treatments. The primary goal is to establish groups of individuals with intellectual disabilities and/or autism spectrum disorders (ASD) sharing the same genetic mutation. This approach will provide a better understanding of the natural history of the disease and associated comorbidities.
It is important to note that this project will only focus on patients for whom the identification of the causal mutation or penetrant copy number variation (CNV) has been determined. It excludes individuals for whom the cause of intellectual disability is unknown.
This approach will contribute to a better understanding of the genetic aspects of intellectual disabilities and ASD, while facilitating more targeted and personalized medical care for the affected patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Institut National de la Santé et de la Recherche Médicale, France | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The studied population includes all patients (and their relatives*) affected by intellectual disability (ID) and/or autism spectrum disorders (ASD) of known genetic origin, on an international scale.
Key inclusion criteria (6 listed)
- Be a voluntary adult (aged 18 or older)
- Be a family member (i.e., mother/father) of patients with intellectual disabilities and/or autism spectrum disorders of known genetic origin. This includes monogenic causes as well as recurrent copy number variations (CNVs) such as deletions or duplications. Note: we also allow adult patients to participate directly if they wish and have the capacity to do so.
- Have knowledge of the genetic cause behind intellectual disabilities or autism spectrum disorders. An exception to this rule is possible for patients with a syndrome that includes intellectual disabilities or autism spectrum disorders, and for whom genetic investigation is considered, with the approval of the project's scientific council (which will define the syndromes eligible for this exception).
- Have the intellectual and material capabilities to complete an internet questionnaire.
- Have read the information sheet regarding the study and agreed to the general conditions of participation in the study.
Key exclusion criteria (2 listed)
- Patients affected by the presence of intellectual disability and/or an autism spectrum disorder of unknown genetic origin will not be able to participate in the study, except with the exception mentioned in the previous chapter.
- It is requested that only adults enter data. However, the collected data may pertain to a minor (in the case of a parent entering data about their minor child)
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
Description of the clinical and "para-clinical" characteristics of the disease over time in adult and pediatric patients, depending on the type of genetic anomaly associated with the disease.
Time frame: Day 1, Every 6 months over 5 years
3 secondary outcomes
Identification of new information regarding the challenges faced by individuals with Intellectual Disability/Autism Spectrum Disorder (ID/ASD), based on their age (pediatric/adult) and type of anomaly (genetic/environmental factor).
Time frame: Day 1, Every 6 months over 5 years
Search for associations between certain phenotypic and genotypic/environmental factor characteristics to which individuals have been exposed.
Time frame: Day 1, Every 6 months over 5 years
Description of the dynamics of exchanges among families (no access to content, description of the number of participating families, frequency of exchanges, etc.)
Time frame: Day 1, Every 6 months over 5 years
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 11 Mar 2026.
- 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.
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 Genetic of Intellectual Deficiency and Autism Spectrum Disorder, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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 6 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: looking for participants now, as of the sponsor's last update on 11 Mar 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 France. 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 Jean-Louis Mandel, Pr (03 88 65 32 10, jean-louis.mandel@igbmc.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the clinical and "para-clinical" characteristics of the disease over time in adult and pediatric patients, depending on the type of genetic anomaly associated with the disease. (time frame: Day 1, Every 6 months over 5 years). 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 11 Mar 2026.