Transplant FailureNCT03587493
T-lymphocytes CD8+/HLA-DR+ and Acute Rejection After Lung Transplantation
A study testing BLOOD SAMPLE ANALYSIS in people with Transplant Failure, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The objectives of the study is to identify associations between acute rejection and the increase of T (CD4/CD8) and B circulating lymphocytes expressing specific markers of activation and differentiation (HLA-DR, CD25, CD38, CD45RO, CCR7). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant Failure
- What is being tested?
- BLOOD SAMPLE ANALYSIS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 13 Aug 2018to Sep 2022
- 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
- >18 years old
- French national waiting list of lung transplantation
- Transplanted in Marseille or Strasbourg (France)
Who cannot join
- <18 years old
- Refused to participate
- Redo lung transplantation
- Other organ transplanted
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, 13354
BENJAMIN COIFFARD, MD, +33 491964355, Benjamin.COIFFARD@ap-hm.fr
About this study
Official title: Activated Cytotoxic T-lymphocytes CD8+/HLA-DR+ and Acute Cellular Rejection After Lung Transplantation
The objectives of the study is to identify associations between acute rejection and the increase of T (CD4/CD8) and B circulating lymphocytes expressing specific markers of activation and differentiation (HLA-DR, CD25, CD38, CD45RO, CCR7).
110 adults over 18 years, on national waiting list for a first lung transplantation in the centers of Marseille and Strasbourg, whatever the lung disease, and who will be transplanted and benefit immunosuppressive induction therapy that specifically targets T lymphocytes will be included. Peripheral venous blood sampling just prior to pulmonary transplantation, at day 15 and one month post-transplant will be realized for lymphocyte phenotyping by flow cytometry (CD45, CD3, CD4, CD8, CD19, HLA-DR, CD25, CD38, CD45RO, CCR7). Acute rejection will be evaluated at 1 month and 1 year post-transplant by trans-bronchial biopsies.
The two main perspectives are to 1) find a specific, non-invasive, blood-based diagnostic marker of acute post-lung transplant rejection with diagnostic performance equivalent to trans-bronchial biopsy 2) demonstrate a specific blood marker, non-invasive, predictive of acute rejection in order to adapt immunosuppressive therapy early and reduce the occurrence of this risk.
Read the detailed description
The objectives of the study is to identify associations between acute rejection and the increase of T (CD4/CD8) and B circulating lymphocytes expressing specific markers of activation and differentiation (HLA-DR, CD25, CD38, CD45RO, CCR7).
110 adults over 18 years, on national waiting list for a first lung transplantation in the centers of Marseille and Strasbourg (France), whatever the lung disease, and who will be transplanted and benefit immunosuppressive induction therapy that specifically targets T lymphocytes will be included. Peripheral venous blood sampling just prior to pulmonary transplantation, at day 15 and one month post-transplant will be realized for lymphocyte phenotyping by flow cytometry (CD45, CD3, CD4, CD8, CD19, HLA-DR, CD25, CD38, CD45RO, CCR7). Acute rejection will be evaluated at 1 month and 1 year post-transplant by trans-bronchial biopsies.
The two main perspectives are to 1) find a specific, non-invasive, blood-based diagnostic marker of acute post-lung transplant rejection with diagnostic performance equivalent to trans-bronchial biopsy 2) demonstrate a specific blood marker, non-invasive, predictive of acute rejection in order to adapt immunosuppressive therapy early and reduce the occurrence of this risk.
- Conditions
- Transplant Failure
- Being tested
- BLOOD SAMPLE ANALYSIS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLOOD SAMPLE ANALYSISOther
Peripheral venous blood sampling just before lung transplantation, at day 15 and at post-transplantation M1 for lymphocyte phenotyping by cytometry
| Study group | Role | What they receive |
|---|---|---|
| EXPERIMENTAL GROUP | Experimental | 110 adults, on national waiting list for a first lung transplantation in the centers of Marseille and Strasbourg, whatever the lung disease, and who will be transplanted and benefit immunosuppressive induction therapy that specifically targets T lymphocytes will be included.
Blood sample analysis will be performed Receives: Other: BLOOD SAMPLE ANALYSIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
T-lymphocytes CD8/HLA-DR+
comparison of the level of T-lymphocytes CD8/HLA-DR+ at day 15 post lung transplantation between recipients who developed acute cellular rejection at 1 month post-transplant and those who not.
Measured: at day 15 post lung transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start13 Aug 2018
- Primary completionAug 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant FailureStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Collaborators
- Vaincre la Mucoviscidose
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587493
- Sponsor's protocol ID
- 2018-09
- Status last verified
- Oct 2021
- First submitted
- 3 Jul 2018
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activated Cytotoxic T-lymphocytes CD8+/HLA-DR+ and Acute Cellular Rejection After Lung Transplantation
- ClinicalTrials.gov ID
- NCT03587493
- Acronym / sponsor ID
- 2018-09
- Conditions
- Transplant Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Collaborators
- Vaincre la Mucoviscidose
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 16 Jul 2018 (actual)
- 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 objectives of the study is to identify associations between acute rejection and the increase of T (CD4/CD8) and B circulating lymphocytes expressing specific markers of activation and differentiation (HLA-DR, CD25, CD38, CD45RO, CCR7).
110 adults over 18 years, on national waiting list for a first lung transplantation in the centers of Marseille and Strasbourg, whatever the lung disease, and who will be transplanted and benefit immunosuppressive induction therapy that specifically targets T lymphocytes will be included. Peripheral venous blood sampling just prior to pulmonary transplantation, at day 15 and one month post-transplant will be realized for lymphocyte phenotyping by flow cytometry (CD45, CD3, CD4, CD8, CD19, HLA-DR, CD25, CD38, CD45RO, CCR7). Acute rejection will be evaluated at 1 month and 1 year post-transplant by trans-bronchial biopsies.
The two main perspectives are to 1) find a specific, non-invasive, blood-based diagnostic marker of acute post-lung transplant rejection with diagnostic performance equivalent to trans-bronchial biopsy 2) demonstrate a specific blood marker, non-invasive, predictive of acute rejection in order to adapt immunosuppressive therapy early and reduce the occurrence of this risk.
Detailed description
The objectives of the study is to identify associations between acute rejection and the increase of T (CD4/CD8) and B circulating lymphocytes expressing specific markers of activation and differentiation (HLA-DR, CD25, CD38, CD45RO, CCR7).
110 adults over 18 years, on national waiting list for a first lung transplantation in the centers of Marseille and Strasbourg (France), whatever the lung disease, and who will be transplanted and benefit immunosuppressive induction therapy that specifically targets T lymphocytes will be included. Peripheral venous blood sampling just prior to pulmonary transplantation, at day 15 and one month post-transplant will be realized for lymphocyte phenotyping by flow cytometry (CD45, CD3, CD4, CD8, CD19, HLA-DR, CD25, CD38, CD45RO, CCR7). Acute rejection will be evaluated at 1 month and 1 year post-transplant by trans-bronchial biopsies.
The two main perspectives are to 1) find a specific, non-invasive, blood-based diagnostic marker of acute post-lung transplant rejection with diagnostic performance equivalent to trans-bronchial biopsy 2) demonstrate a specific blood marker, non-invasive, predictive of acute rejection in order to adapt immunosuppressive therapy early and reduce the occurrence of this risk.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL GROUP | Experimental | Other: BLOOD SAMPLE ANALYSIS110 adults, on national waiting list for a first lung transplantation in the centers of Marseille and Strasbourg, whatever the lung disease, and who will be transplanted and benefit immunosuppressive induction therapy that specifically targets T lymphocytes will be included. Blood sample analysis will be performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years old
- French national waiting list of lung transplantation
- Transplanted in Marseille or Strasbourg (France)
Key exclusion criteria (4 listed)
- <18 years old
- Refused to participate
- Redo lung transplantation
- Other organ transplanted
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 SAMPLE ANALYSISPeripheral venous blood sampling just before lung transplantation, at day 15 and at post-transplantation M1 for lymphocyte phenotyping by cytometry | Other | EXPERIMENTAL GROUP |
Primary outcome
T-lymphocytes CD8/HLA-DR+
Time frame: at day 15 post lung transplantation
comparison of the level of T-lymphocytes CD8/HLA-DR+ at day 15 post lung transplantation between recipients who developed acute cellular rejection at 1 month post-transplant and those who not.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
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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.
EMILIE GARRIDO PRADALIE study director
APHM
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 SAMPLE ANALYSIS in people with Transplant Failure, run by Assistance Publique Hopitaux De Marseille 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 3 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: status not confirmed, as of the sponsor's last update on 29 Oct 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BENJAMIN COIFFARD, MD (+33 491964355, Benjamin.COIFFARD@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T-lymphocytes CD8/HLA-DR+ (time frame: at day 15 post lung transplantation). 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 29 Oct 2021.