Cystic Fibrosis PatientNCT02550041
Analysis T Cells Response for Identification of Aspergillus Bronchitis With Cystic Fibrosis Patients
A study testing T specific response for diagnostic of aspergillus bronchitis in people with Cystic Fibrosis Patient and Patient Without Treatment Against A.Fumigatus, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The study aims to asses the ability of cell tests based on the analysis of the anti-Aspergillus cell responses and identify Aspergillus bronchitis with patients with cystic fibrosis. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Cystic Fibrosis Patient, Patient Without Treatment Against A.Fumigatus
- What is being tested?
- T specific response for diagnostic of aspergillus bronchitis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2015to Jun 2017
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with cystic fibrosis followed at Resource Centers and Cystic Fibrosis Skills (CRCM) Montpellier
- Patient aged 15 or over
- Patient able to understand the nature, purpose and methodology of the study.
- Patient and his legal representative for minors who have given their free and informed consent
- Affiliate or beneficiary of a social security scheme.
Who cannot join
- Patients on antifungal treatment at the time of sampling
- Pregnant or breastfeeding
- Major protected by law (guardianship, curator or under Backup Justice)
- Inability to understand the nature and goals of the study and / or communication difficulties with the investigator
- Subject attending another search including a period of exclusion still going to run-in
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to asses the ability of cell tests based on the analysis of the anti-Aspergillus cell responses and identify Aspergillus bronchitis with patients with cystic fibrosis.
In addition, the study will evaluate the contribution of biological classification of aspergillosis according to criteria recently proposed by Baxter et al. compared to the classification used in clinical practice in the hospital of Montpellier.
- Being tested
- T specific response for diagnostic of aspergillus bronchitis
- Keywords
- Bronchitis aspergillus, cystic fibrosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T specific response for diagnostic of aspergillus bronchitisOther
| Study group | Role | What they receive |
|---|---|---|
| Cystic fibrosis | Other | Not described Receives: Other: T specific response for diagnostic of aspergillus bronchitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of CD4 T cell response against Aspergillus fumigatus in patients with cystis fibrosis
Analysis T cells response for identification of aspergillus bronchitis with cystic fibrosis patients
Measured: 12 months
Cytokine level of TCD8
Qualitative Evaluation of cytokine level (IFNg, TNFa, IL10 and IL4) of TCD8 to identify ABPA and aspergillus bronchitis
Measured: 12 months
Cytokine level CD4 cells
Qualitative Evaluation of cytokine level CD4 cells in order to identify ABPA and aspergillus bronchitis
Measured: 12 months
Secondary outcomes (9)
Level of fumigatus specific IgE
Contribution of several biological tests improve classification of aspergillus bronchitis
Measured: 12 months
Level of fumigatus specific IgG
Contribution of several biological tests improve classification of aspergillus bronchitis
Measured: 12 months
Real-time PCR for aspergillus in sputum
Contribution of several biological tests improve classification of aspergillus bronchitis
Measured: 12 months
Galactomannan by enzyme immune assay detection in sputum
Contribution of several biological tests improve classification of aspergillus bronchitis
Measured: 12 months
Levels of cytokine (IFNg, IL10, IL4 and TNF) evaluated by flow cytometry
Contribution of several biological tests improve classification of aspergillus bronchitis
Measured: 12 months
Level of IL10 evaluated by Elispot dedicated to anti-aspergillus CD4 T cells
Contribution of several biological tests improve classification of aspergillus bronchitis
Measured: 12 months
Flow cytometry techniques dedicated to anti-aspergillus CD4 T cell assessment
Measured: 12 months
Level of IFNg evaluated by Elispot dedicated to anti-aspergillus CD4 T cells
Contribution of several biological tests improve classification of aspergillus bronchitis
Measured: 12 months
Elispot dedicated to anti-aspergillus CD4 T cell
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study start7 Sep 2015
- Primary completion7 Sep 2016
- Study completionJun 2017
Why it stopped: Difficulties for inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis PatientStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550041
- Sponsor's protocol ID
- UF 9582
- Status last verified
- Dec 2016
- First submitted
- 20 Aug 2015
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis T Cells Response for Identification of Aspergillus Bronchitis With Cystic Fibrosis Patients
- ClinicalTrials.gov ID
- NCT02550041
- Acronym / sponsor ID
- UF 9582
- Keywords
- Bronchitis aspergillus, cystic fibrosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties for inclusions
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 7 Sep 2015 (actual)
- Primary completion
- 7 Sep 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 15 Sep 2015 (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 study aims to asses the ability of cell tests based on the analysis of the anti-Aspergillus cell responses and identify Aspergillus bronchitis with patients with cystic fibrosis.
In addition, the study will evaluate the contribution of biological classification of aspergillosis according to criteria recently proposed by Baxter et al. compared to the classification used in clinical practice in the hospital of Montpellier.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cystic fibrosis | Other | Other: T specific response for diagnostic of aspergillus bronchitis |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with cystic fibrosis followed at Resource Centers and Cystic Fibrosis Skills (CRCM) Montpellier
- Patient aged 15 or over
- Patient able to understand the nature, purpose and methodology of the study.
- Patient and his legal representative for minors who have given their free and informed consent
- Affiliate or beneficiary of a social security scheme.
Key exclusion criteria (5 listed)
- Patients on antifungal treatment at the time of sampling
- Pregnant or breastfeeding
- Major protected by law (guardianship, curator or under Backup Justice)
- Inability to understand the nature and goals of the study and / or communication difficulties with the investigator
- Subject attending another search including a period of exclusion still going to run-in
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 |
|---|---|---|
| T specific response for diagnostic of aspergillus bronchitis | Other | Cystic fibrosis |
Primary outcome
Number of CD4 T cell response against Aspergillus fumigatus in patients with cystis fibrosis
Time frame: 12 months
Analysis T cells response for identification of aspergillus bronchitis with cystic fibrosis patients
Cytokine level of TCD8
Time frame: 12 months
Qualitative Evaluation of cytokine level (IFNg, TNFa, IL10 and IL4) of TCD8 to identify ABPA and aspergillus bronchitis
Cytokine level CD4 cells
Time frame: 12 months
Qualitative Evaluation of cytokine level CD4 cells in order to identify ABPA and aspergillus bronchitis
9 secondary outcomes
Level of fumigatus specific IgE
Time frame: 12 months
Level of fumigatus specific IgG
Time frame: 12 months
Real-time PCR for aspergillus in sputum
Time frame: 12 months
Galactomannan by enzyme immune assay detection in sputum
Time frame: 12 months
Levels of cytokine (IFNg, IL10, IL4 and TNF) evaluated by flow cytometry
Time frame: 12 months
Level of IL10 evaluated by Elispot dedicated to anti-aspergillus CD4 T cells
Time frame: 12 months
Flow cytometry techniques dedicated to anti-aspergillus CD4 T cell assessment
Time frame: 12 months
Level of IFNg evaluated by Elispot dedicated to anti-aspergillus CD4 T cells
Time frame: 12 months
Elispot dedicated to anti-aspergillus CD4 T cell
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Difficulties for inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T specific response for diagnostic of aspergillus bronchitis in people with Cystic Fibrosis Patient and Patient Without Treatment Against A.Fumigatus, run by University Hospital, Montpellier 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 9 May 2019. 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 was stopped early (reason given: Difficulties for inclusions). Results are not available in the source record.
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?
Number of CD4 T cell response against Aspergillus fumigatus in patients with cystis fibrosis (time frame: 12 months). The study lists 3 primary outcomes in all. 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 May 2019.