Lung TransplantRHUM-TPNCT01791166
Immuno-humoral Rejection Markers in Pulmonary Transplant
A study testing Blood test for detecting the circulatory anti-HLA antibodies by ELISA and LUMINEX tests in people with Lung Transplant, run by Hopital Foch at 1 site in France.
Trial summary
Open multicentric prospective study performed on pulmonary transplanted patients to detect the values of different diagnostic markers for immuno- humoral reaction and their roles in the humoral rejection for those patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant
- What is being tested?
- Blood test for detecting the circulatory anti-HLA antibodies by ELISA and LUMINEX tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2011to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both genders, more than 18 years of age.
- Patients with or without Cystic fibrosis
- Patients with no previous unilateral or bilateral pulmonary transplant or cardiopulmonary transplant
- Patients with no current other disease can affect, in short term, the process or prognosis of the transplant
- Patients had given his agreement to be enrolled in the study
Who cannot join
- Patient less than 18 year-old
- Patient had previous organ transplant
- Pregnant and/or lactating women
- Female subject in reproductive age does not use effective contraceptive methode
- Alcoholisms or neuropsychosis, conditions that affect the good comprehension of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Humoral Rejection - Diagnostic Markers in Pulmonary Transplant.
Open multicentric prospective study performed on pulmonary transplanted patients to detect the values of different diagnostic markers for immuno- humoral reaction and their roles in the humoral rejection for those patients.
- Conditions
- Lung Transplant
- Being tested
- Blood test for detecting the circulatory anti-HLA antibodies by ELISA and LUMINEX tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood test for detecting the circulatory anti-HLA antibodies by ELISA and LUMINEX testsBiological
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary transplant | Experimental | Not described Receives: Biological: Blood test for detecting the circulatory anti-HLA antibodies by ELISA and LUMINEX tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of immune Markers of acute lung transplant rejection (Anti-HLA circulatory antibodies, neutrophils and C4d immune markers.
Measured: 12 months after pulmonary transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startFeb 2011
- Primary completionOct 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791166
- Sponsor's protocol ID
- 2010/49
- Acronym
- RHUM-TP
- Status last verified
- Sep 2016
- First submitted
- 12 Feb 2013
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humoral Rejection - Diagnostic Markers in Pulmonary Transplant.
- ClinicalTrials.gov ID
- NCT01791166
- Acronym / sponsor ID
- RHUM-TP / 2010/49
- Conditions
- Lung Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 13 Feb 2013 (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.
Open multicentric prospective study performed on pulmonary transplanted patients to detect the values of different diagnostic markers for immuno- humoral reaction and their roles in the humoral rejection for those patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary transplant | Experimental | Biological: Blood test for detecting the circulatory anti-HLA antibodies by ELISA and LUMINEX tests |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Both genders, more than 18 years of age.
- Patients with or without Cystic fibrosis
- Patients with no previous unilateral or bilateral pulmonary transplant or cardiopulmonary transplant
- Patients with no current other disease can affect, in short term, the process or prognosis of the transplant
- Patients had given his agreement to be enrolled in the study
Key exclusion criteria (5 listed)
- Patient less than 18 year-old
- Patient had previous organ transplant
- Pregnant and/or lactating women
- Female subject in reproductive age does not use effective contraceptive methode
- Alcoholisms or neuropsychosis, conditions that affect the good comprehension of the study
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 test for detecting the circulatory anti-HLA antibodies by ELISA and LUMINEX tests | Biological | Pulmonary transplant |
Primary outcome
Incidence of immune Markers of acute lung transplant rejection (Anti-HLA circulatory antibodies, neutrophils and C4d immune markers.
Time frame: 12 months after pulmonary transplant
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 12 Sep 2016.
- 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.
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 Blood test for detecting the circulatory anti-HLA antibodies by ELISA and LUMINEX tests in people with Lung Transplant, run by Hopital Foch 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: finished, as of the sponsor's last update on 12 Sep 2016. 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?
Incidence of immune Markers of acute lung transplant rejection (Anti-HLA circulatory antibodies, neutrophils and C4d immune markers. (time frame: 12 months after pulmonary transplant). 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 12 Sep 2016.