Type 1 DiabetesLymphoscreenNCT01042301
Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes
A study testing Blood samplings in people with Type 1 Diabetes, run by Nantes University Hospital at 1 site in France.
Trial summary
The "Lymphoscreen" study aims to characterize precisely (phenotypes/cytokines/functions) CD8+ T cell responses in type 1 Diabetes to identify biomarkers of the disease. Such markers are needed for refine type 1 Diabetes diagnosis/prognostic, and to design new therapeutic approaches targeting autoreactive CD8+ T cells. Read more about this study
- Who is it for?
- Ages 7 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Blood samplings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2007to Oct 2014
- Phase
- Interventional
- 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 7 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- at least, 50 patients with "recent" type 1 diabetes,
- 30 patients with long-term type 1 diabetes,
- 10 patients with Latent Autoimmune Diabetes,
- 10 subjects with a risk for diabetes,
- 20 type 1 diabetic patients with pancreatic graft or Langerhans islet graft.
- 50 healthy subjects paired to HLA class I and to the age
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- Those subjects have to respect the following criteria :
- Age from 7 to 70 -Caucasian
- Affiliated to a national insurance scheme
- Written informed consent obtained For children, written informed consent is required from the two parents.
- Non-inclusion criteria :
- Age strictly inferior to 7 or strictly superior to 70 years old
- Pregnancy
- Secondary diabetes
- No written informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The "Lymphoscreen" study aims to characterize precisely (phenotypes/cytokines/functions) CD8+ T cell responses in type 1 Diabetes to identify biomarkers of the disease. Such markers are needed for refine type 1 Diabetes diagnosis/prognostic, and to design new therapeutic approaches targeting autoreactive CD8+ T cells. An original approach using DNA immunization of humanized mice allowed us to identify relevant CD8 epitopes derived from GAD65 and IA-2 beta cell autoantigens. The aims are: (i) identifying exhaustively epitopes recognized by autoreactive CD8+ T lymphocytes in type 1 Diabetes and following islet or pancreas graft in humans; (ii) identifying pathogenic CD8+ T cell patterns or profiles related to type 1 Diabetes pathogenesis and evolution; (iii) correlating CD8+ autoreactive T cell responses and autoantibody responses to new cellular (such as CD4+ T cells or peripheral cell miRNA) or humoral markers of the disease (such as serum miRNA).
- Conditions
- Type 1 Diabetes
- Being tested
- Blood samplings
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingsOther
| Study group | Role | What they receive |
|---|---|---|
| Long-term type 1 diabetic patients | Experimental | Long-term type 1 diabetic patients Receives: Other: Blood samplings |
| control patients | Active comparator | control patients Receives: Other: Blood samplings |
| diabetic and transplanted patients | Experimental | diabetic and transplanted patients Receives: Other: Blood samplings |
| subjects with high risk for diabetes | Experimental | subjects with high risk for diabetes Receives: Other: Blood samplings |
| patients with recent type 1 diabetes | Experimental | patients with recent type 1 diabetes Receives: Other: Blood samplings |
| patients with Latent Autoimmune Diabetes | Experimental | patients with Latent Autoimmune Diabetes Receives: Other: Blood samplings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification and characterization of new CD8+ T lymphocytes related to type 1 diabetes and its evolution (2009-2012)
Measured: 3 years
Secondary outcomes (1)
Identification and characterization of new profiles of humoral and cellular markers (including T cell reactivity and miRNA) related to type 1 diabetes (2010-2014).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study startSep 2007
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucy Chaillous, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042301
- Sponsor's protocol ID
- BRD07/5-A
- Acronym
- Lymphoscreen
- Status last verified
- Sep 2015
- First submitted
- 4 Jan 2010
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01042301
- Acronym / sponsor ID
- Lymphoscreen / BRD07/5-A
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 5 Jan 2010 (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 "Lymphoscreen" study aims to characterize precisely (phenotypes/cytokines/functions) CD8+ T cell responses in type 1 Diabetes to identify biomarkers of the disease. Such markers are needed for refine type 1 Diabetes diagnosis/prognostic, and to design new therapeutic approaches targeting autoreactive CD8+ T cells. An original approach using DNA immunization of humanized mice allowed us to identify relevant CD8 epitopes derived from GAD65 and IA-2 beta cell autoantigens. The aims are: (i) identifying exhaustively epitopes recognized by autoreactive CD8+ T lymphocytes in type 1 Diabetes and following islet or pancreas graft in humans; (ii) identifying pathogenic CD8+ T cell patterns or profiles related to type 1 Diabetes pathogenesis and evolution; (iii) correlating CD8+ autoreactive T cell responses and autoantibody responses to new cellular (such as CD4+ T cells or peripheral cell miRNA) or humoral markers of the disease (such as serum miRNA).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Long-term type 1 diabetic patients | Experimental | Other: Blood samplingsLong-term type 1 diabetic patients |
| control patients | Active comparator | Other: Blood samplingscontrol patients |
| diabetic and transplanted patients | Experimental | Other: Blood samplingsdiabetic and transplanted patients |
| subjects with high risk for diabetes | Experimental | Other: Blood samplingssubjects with high risk for diabetes |
| patients with recent type 1 diabetes | Experimental | Other: Blood samplingspatients with recent type 1 diabetes |
| patients with Latent Autoimmune Diabetes | Experimental | Other: Blood samplingspatients with Latent Autoimmune Diabetes |
Who may qualify
- Ages
- 7 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- at least, 50 patients with "recent" type 1 diabetes,
- 30 patients with long-term type 1 diabetes,
- 10 patients with Latent Autoimmune Diabetes,
- 10 subjects with a risk for diabetes,
- 20 type 1 diabetic patients with pancreatic graft or Langerhans islet graft.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplings | Other | Long-term type 1 diabetic patients, control patients, diabetic and transplanted patients, patients with Latent Autoimmune Diabetes, patients with recent type 1 diabetes, subjects with high risk for diabetes |
Primary outcome
Identification and characterization of new CD8+ T lymphocytes related to type 1 diabetes and its evolution (2009-2012)
Time frame: 3 years
1 secondary outcome
Identification and characterization of new profiles of humoral and cellular markers (including T cell reactivity and miRNA) related to type 1 diabetes (2010-2014).
Time frame: 3 years
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 9 Sep 2015.
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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.
Lucy Chaillous principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samplings in people with Type 1 Diabetes, run by Nantes University Hospital 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 15 inclusion and 0 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 9 Sep 2015. 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?
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?
Identification and characterization of new CD8+ T lymphocytes related to type 1 diabetes and its evolution (2009-2012) (time frame: 3 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 9 Sep 2015.