Hypereosinophilic SyndromeSHENCT01713504
Identification of New Markers in the Hypereosinophilic Syndrome
A study testing biologie sample in people with Hypereosinophilic Syndrome, run by University Hospital, Lille at 1 site in France.
Trial summary
The purpose is to characterize new hypereosinophilic syndrome biomarkers more informative and more accessible compared to those that we have already thanks to a proteomic approach. This will help the investigators to diagnose the this disease. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypereosinophilic Syndrome
- What is being tested?
- biologie sample
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jun 2010to Jul 2015
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- dated and signed informed consent
- virale serology negative or negative result less than 6 months
- virale serology negative for HBV or vaccinated patient
- insured
- virale serology negative or negative result less than 6 months
- negative pregnancy test or female menopause for at least 1 year
Who cannot join
- subject enable adult, under guardianship or under protective measures of justice
- Refusal or inability to give informed consent
- The hypereosinophilic syndrome explained origin other than than atopy, bullous pemphigoid, the Churg-Strauss syndrome and DRESS
Trial locations and contacts
1 site in 1 country.
About this study
The purpose is to characterize new hypereosinophilic syndrome biomarkers more informative and more accessible compared to those that we have already thanks to a proteomic approach. This will help the investigators to diagnose the this disease.
- Conditions
- Hypereosinophilic Syndrome
- Being tested
- biologie sample
- Medical subject headings
- Hypereosinophilic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biologie sampleBiological
comparison of biomarkers between HES, HE biomarkers data and control arms
| Study group | Role | What they receive |
|---|---|---|
| Hypereosinophilic syndrome unexplained | Experimental | Not described Receives: Biological: biologie sample |
| Hypereosinophilic syndrome explained | Active comparator | Not described Receives: Biological: biologie sample |
| Normal rate of eosinophilic | Sham comparator | Not described Receives: Biological: biologie sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
The aim is to characterize, through an approach immunoprotéomique, new HES biomarkers more informative and easier access than those currently available to us. These biomarkers will help to the diagnosis of HES, compared with other causes of eosinophilia.
Measured: one month after patient inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study start29 Jun 2010
- Primary completionJul 2015
- Study completionJul 2015
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 Hypereosinophilic SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lionel Prin, MD PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713504
- Sponsor's protocol ID
- 2008_29
- Other IDs
- 2009-A00314-53
- Acronym
- SHE
- Status last verified
- Jan 2026
- First submitted
- 22 Oct 2012
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lefevre G, Copin MC, Roumier C, Aubert H, Avenel-Audran M, Grardel N, Poulain S, Staumont-Salle D, Seneschal J, Salles G, Ghomari K, Terriou L, Leclech C, Morati-Hafsaoui C, Morschhauser F, Lambotte O, Ackerman F, Trauet J, Geffroy S, Dumezy F, Capron M, Roche-Lestienne C, Taieb A, Hatron PY, Dubucquoi S, Hachulla E, Prin L, Labalette M, Launay D, Preudhomme C, Kahn JE; French Eosinophil Network. CD3-CD4+ lymphoid variant of hypereosinophilic syndrome: nodal and extranodal histopathological and immunophenotypic features of a peripheral indolent clonal T-cell lymphoproliferative disorder. Haematologica. 2015 Aug;100(8):1086-95. doi: 10.3324/haematol.2014.118042. Epub 2015 Feb 14.
PubMed 25682606
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of New Markers in the Hypereosinophilic Syndrome
- ClinicalTrials.gov ID
- NCT01713504
- Acronym / sponsor ID
- SHE / 2008_29
- Conditions
- Hypereosinophilic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 29 Jun 2010 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 24 Oct 2012 (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 is to characterize new hypereosinophilic syndrome biomarkers more informative and more accessible compared to those that we have already thanks to a proteomic approach. This will help the investigators to diagnose the this disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypereosinophilic syndrome unexplained | Experimental | Biological: biologie sample |
| Hypereosinophilic syndrome explained | Active comparator | Biological: biologie sample |
| Normal rate of eosinophilic | Sham comparator | Biological: biologie sample |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- dated and signed informed consent
- virale serology negative or negative result less than 6 months
- virale serology negative for HBV or vaccinated patient
- insured
- virale serology negative or negative result less than 6 months
Key exclusion criteria (3 listed)
- subject enable adult, under guardianship or under protective measures of justice
- Refusal or inability to give informed consent
- The hypereosinophilic syndrome explained origin other than than atopy, bullous pemphigoid, the Churg-Strauss syndrome and DRESS
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 |
|---|---|---|
| biologie samplecomparison of biomarkers between HES, HE biomarkers data and control arms | Biological | Hypereosinophilic syndrome explained, Hypereosinophilic syndrome unexplained, Normal rate of eosinophilic |
Primary outcome
The aim is to characterize, through an approach immunoprotéomique, new HES biomarkers more informative and easier access than those currently available to us. These biomarkers will help to the diagnosis of HES, compared with other causes of eosinophilia.
Time frame: one month after patient inclusion
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 8 Jan 2026.
- Results publication: PubMed 25682606Lefevre G, Copin MC, Roumier C, Aubert H, Avenel-Audran M, Grardel N, Poulain S, Staumont-Salle D, Seneschal J, Salles G, Ghomari K, Terriou L, Leclech C, Morati-Hafsaoui C, Morschhauser F, Lambotte O, Ackerman F, Trauet J, Geffroy S, Dumezy F, Capron M, Roche-Lestienne C, Taieb A, Hatron PY, Dubucquoi S, Hachulla E, Prin L, Labalette M, Launay D, Preudhomme C, Kahn JE; French Eosinophil Network. CD3-CD4+ lymphoid variant of hypereosinophilic syndrome: nodal and extranodal histopathological and immunophenotypic features of a peripheral indolent clonal T-cell lymphoproliferative disorder. Haematologica. 2015 Aug;100(8):1086-95. doi: 10.3324/haematol.2014.118042. Epub 2015 Feb 14.
- 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. This study is not recruiting at the moment.
Lionel Prin, MD PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biologie sample in people with Hypereosinophilic Syndrome, run by University Hospital, Lille 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 3 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 8 Jan 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. Some participants in this study may receive a placebo. 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?
The aim is to characterize, through an approach immunoprotéomique, new HES biomarkers more informative and easier access than those currently available to us. These biomarkers will help to the diagnosis of HES, compared with other causes of eosinophilia. (time frame: one month after patient inclusion). 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 NCT01713504, 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 8 Jan 2026.