Down Syndrome With and Without Auto Immune AbnormalitiesIMMUTRINCT01041469
Pilot Study of Auto-immune Abnormalities Associated With Down Syndrome
An observational study of Down Syndrome With and Without Auto Immune Abnormalities, run by Institut Jerome Lejeune at 2 sites in France.
Trial summary
The purpose of the study is to identify biological data linked to auto immune abnormalities associated with Down Syndrome. Read more about this study
- Who is it for?
- Ages 8 to 36 years
- Conditions the study is for
- Down Syndrome With and Without Auto Immune Abnormalities
- How many people
- 72 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2009to Dec 2010
- 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 8 to 36 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Down syndrome patients followed in a specialized clinic devoted to healthcare of mentally retarded children and adults
Who may be able to join
- Free and complete trisomy 21
- aged between 8 and 36 years
- biological or clinical signs of auto-immune disorder (group 1)
- no sign of auto-immune disorder (group 2)
Who cannot join
- any antimitotic or immune depressing treatment during the last 6 months
- Current infectious disease
- Corticosteroid therapy in the last 3 weeks
- pregnancy
Trial locations and contacts
2 sites in 1 country.
France2 sites
Institut Jerome Lejeune
Paris, 75015
Laboratoire d'Immunologie Biologique (Unité INSERM U580)
Paris, 75743
About this study
The purpose of the study is to identify biological data linked to auto immune abnormalities associated with Down Syndrome.
- Keywords
- Down syndrome, Humans,Clinical study,Immunity, Autoimmunity,
- Medical subject headings
- Down Syndrome, Autoimmune 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 |
|---|---|---|
| with abnormalities | Down syndrome patients presenting with at least one sign of auto immune abnormality | |
| without abnormality | Down syndrome patients without any sign of recognized auto immune condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Auto-antibodies dosage
Measured: at enrolment
specific lymphocytes populations count
Measured: at enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2009 (estimated)
- Study startNov 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Down Syndrome With and Without Auto Immune AbnormalitiesStudies 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
- Cross-sectional
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Jerome Lejeune
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Jérôme Lejeune
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041469
- Sponsor's protocol ID
- IJL-IMM-EP10
- Acronym
- IMMUTRI
- Status last verified
- Dec 2009
- First submitted
- 30 Dec 2009
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Friedman DL, Kastner T, Pond WS, O'Brien DR. Thyroid dysfunction in individuals with Down syndrome. Arch Intern Med. 1989 Sep;149(9):1990-3.
PubMed 2528336
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Auto-immune Abnormalities Associated With Down Syndrome
- ClinicalTrials.gov ID
- NCT01041469
- Acronym / sponsor ID
- IMMUTRI / IJL-IMM-EP10
- Keywords
- Down syndrome, Humans,Clinical study,Immunity, Autoimmunity,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Institut Jerome LejeuneUniversity, hospital or other
- Collaborators
- Fondation Jérôme Lejeune
- Study start
- Nov 2009
- Study completion
- Dec 2010 (actual)
- First posted
- 31 Dec 2009 (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.
The purpose of the study is to identify biological data linked to auto immune abnormalities associated with Down Syndrome.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with abnormalities | – | –Down syndrome patients presenting with at least one sign of auto immune abnormality |
| without abnormality | – | –Down syndrome patients without any sign of recognized auto immune condition |
Who may qualify
- Ages
- 8 to 36 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Down syndrome patients followed in a specialized clinic devoted to healthcare of mentally retarded children and adults
Key inclusion criteria (4 listed)
- Free and complete trisomy 21
- aged between 8 and 36 years
- biological or clinical signs of auto-immune disorder (group 1)
- no sign of auto-immune disorder (group 2)
Key exclusion criteria (4 listed)
- any antimitotic or immune depressing treatment during the last 6 months
- Current infectious disease
- Corticosteroid therapy in the last 3 weeks
- pregnancy
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
Auto-antibodies dosage
Time frame: at enrolment
specific lymphocytes populations count
Time frame: at enrolment
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 22 Mar 2012.
- Background: PubMed 2528336Friedman DL, Kastner T, Pond WS, O'Brien DR. Thyroid dysfunction in individuals with Down syndrome. Arch Intern Med. 1989 Sep;149(9):1990-3.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Down Syndrome With and Without Auto Immune Abnormalities, run by Institut Jerome Lejeune at 2 sites 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 4 inclusion and 4 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 22 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Auto-antibodies dosage (time frame: at enrolment). 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 NCT01041469, which also lists 1 linked publication.
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 22 Mar 2012.